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Surgical management of pelvic organ prolapse in women

  1. Christopher Maher1,*,
  2. Benjamin Feiner2,
  3. Kaven Baessler3,
  4. Corina Schmid4

Editorial Group: Cochrane Incontinence Group

Published Online: 30 APR 2013

Assessed as up-to-date: 20 AUG 2012

DOI: 10.1002/14651858.CD004014.pub5


How to Cite

Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004014. DOI: 10.1002/14651858.CD004014.pub5.

Author Information

  1. 1

    Royal Brisbane Women's Hospital, Brisbane, Queensland, Australia

  2. 2

    Hillel Yaffe Medical Center, Division of Urogynecology, Hadera, Israel

  3. 3

    Pelvic Floor Centre Charite, Urogynaecology Department, Berlin, Germany

  4. 4

    Royal Brisbane Hospital and Wesley Urogynaecolgy, Brisbane, Australia

*Christopher Maher, Royal Brisbane Women's Hospital, University Queensland, Brisbane, Queensland, Australia. chrismaher@urogynaecology.com.au.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 30 APR 2013

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This is not the most recent version of the article. View current version (30 NOV 2016)

 
Characteristics of included studies [ordered by study ID]
Al-Nazer 2007

MethodsSingle centre RCT for stage 2 POP-Q prolapse

PC generated randomisation

2 year follow up

No CONSORT statement

Blinding not stated

power of 80% need sample size of 20 in each arm if subsequent prolapse surgery in one group 11% and 44% in mesh group


Participants40 randomised

Inclusion criteria: stage 2 POP-Q cystocele with no plans of pregnancy in 12 months

Exclusion criteria: contemplating pregnancy, patients with paravaginal defects, needing continence surgery, prior colposuspension, or vaginal surgery, immunocompromised or diabetics


InterventionsA (n=23): anterior colporrhaphy AC 0 polyglactan vicryl suture

B (n=21): self-styled armless soft polypropylene (Gynemesh) mesh without AC


Outcomessubjective persistence of symptom vaginal bulge Gp A 6/23 Gp B 1/21

improved objective assessment in Gp B as compared to Gp A in relation to POP-Q points Aa and Ba

objective failure rate Stage 2 POPQ at Aa, Ba, Ap or Bp: Gp A 9/23 Gp B 2/21

de novo dyspareunia Gp A 1/23 Gp B 0/21

de novo SUI Gp A 2/20 Gp B 0/20

de novo OAB Gp A 2/20 Gp B 0/20

cystotomy Gp A 0/20 Gp B 0/20

mesh erosion Gp A 0/20 Gp B 1/20


Notespre-operative data was supplied on 20 patients in each group and post-operative data related to Gp A 23 Gp B 21


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPC generated randomisation

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskno data

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo data

Incomplete outcome data (attrition bias)
All outcomes
Low riskData seem complete

Other biasUnclear riskfunding not stated authors no COI

Ali 2006 abstract

MethodsSingle centre RCT

Inclusion grade 3 or 4 cystourethrocele (BW halfway system)

No exclusion

No power

Randomisation and concealment, blinding NS

6/12 follow up


ParticipantsNo CONSORT

N=108

Inclusion: women with grade 3 or 4 cystourethrocele (BW halfway system)

There were no significant differences between the groups regarding pre-operative storage symptoms, urodynamics and degree of prolapse


InterventionsA (54): anterior colporrhaphy alone

B (54): anterior colporrhaphy with tension-free polypropylene (Gynemesh PS) overlay


OutcomesFailure was defined as grade 2 or worse anterior wall prolapse

Objective failure at 6 months: A 5/43; B 3/46 (P>0.5)

Blood loss: A 50.3±89 ml; B 64.5±70.4

Mesh erosion: A 0, B 3/46


Notes   


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear risknot stated

Allahdin 2008

MethodsSingle centre RCT comparing vaginal fascial repair with or without polyglactin mesh and with polydioxanone or polyglactin sutures, 2x2 factorial design

PC randomisation, "secure" remote concealment

Blinded patients, ward staff and follow-up assessor

Follow up 3 months with exam, 6 months with non-validated questionnaire, 2 years with validated questionnaire


Participants73 randomised, 7 ineligible after randomisation, 66 in trial

Lost to follow up: 8 at 3 and 4 at 6 months, 12 at 2 years

Inclusion: grade 2 or more prolapse (unclear examination technique), anterior and/or posterior prolapse

Concomitant procedures: vaginal hysterectomy 14; cervical amputation (Manchester) 18; TVT 13


InterventionsA (32): repair with polyglactin mesh overlay

B (34): repair without mesh

C (33): repair of fascia with polydioxanone sutures

D (33): repair of fascia with polyglactin sutures


OutcomesAt 3months:  6/58 (10%) with residual stage 2 anterior vaginal wall prolapse (A 2/32, B 4/32, C 4/33, D 2/33)

Questionnaire mean prolapse symptom score (POP-SS, 0-28) (mean, SD, n): At 6 months:  A 4.4(4.8)29, B 4.3(5.4)33, C 5.1(5.1)29, D 3.6(5.0)33;  At 2 years:  A 4.3(4.2)25, B 4.3(6.3)29, C 5.5(6.3)26, D 3.2(4.2)28

No. of women with residual prolapse symptoms at 6 months: A 24/29, B 24/33, C 25/29 and D 23/33;  at 2 years: A 19/25, B 21/29, C 21/26, D 19/28

Questionnaire mean prolapse QoL score (0-10) (mean, SD, n):  At 6 months: A 1.6(2.9)28, B 1.5(2.8)33, C 2.0(3.1)28, D 1.2(2.5)33;  At 2 years: A 1.5(3.0)23, B 1.8(3.5)29, C 2.5(4.1)24, D 0.9(2.1)28 

No. of women with quality of life still affected by prolapse:  At 6 months: A 10/28, B 13/33, C 11/28 and D 12/33 women;  At 2 years: A 9/23, B 8/29, C 9/24, D 8/28 

Number of women with urinary incontinence at 2 years: A 18/22, B 16/27, C 16/23, D 18/26

Urinary symptoms (ICI score 0-21):  At 2 years: A 4.2(3.9)25, B 4.6(5.5)29, C 5.5(5.9)26, D 3.5(3.3)28

Dyspareunia at 2 years:  A 3/9, B 3/12, C 2/11, D 4/10

Death: A 2/32, B 0/34, C 1/33, D 1/33

Repeat prolapse surgery: A 2/32, B 4/34, C 3/33, D 3/33

Notes of all non-responders at 2 years obtained for follow up


NotesNo CONSORT or power calculation as it was a feasibility study, no separate objective assessment in groups, validated prolapse symptom and urinary symptom questionnaires.

The authors randomised 66 women with grade 2 or more prolapse to receive anterior and/or posterior vaginal surgery with or without polyglactin mesh overlay and with polydioxanone or with polyglactin sutures for the repair of the pubocervical and rectovaginal fascia. At three months follow up with examination 6/58 women had stage 2 anterior vaginal prolapse without a significant difference between groups. At six months FU a postal questionnaire was completed by 62 women and at 2 years by 54 women. There were no differences between groups with prolapse symptoms.

The study is limited due to no power calculation, no objective report of prolapse examination separately in groups.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated

Allocation concealment (selection bias)Low riskSecure method of concealment of randomisation (remote computer allocation)

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNot possible

Blinding of outcome assessment (detection bias)
All outcomes
Low riskParticipant-completed questionnaires, data entry blinded to randomisation

Incomplete outcome data (attrition bias)
All outcomes
Low riskEqual non-response between the groups, medical records seen for all non-responders

Other biasLow riskUnfunded study

Altman 2011

MethodsMulti-centre RCT 53 centres, 58 surgeons

90% powered to detect 20% difference between groups with 1% type one error, central randomisation PC

patient blinded

reviews conducted 2 and 12 months by surgeon 1/3, non-surgeon 2/3

completed pre and 1 year Urogenital Distress Inventory (UDI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)


Participants1685 screened 389 randomised

underwent surgery: A 182; B 191

lost to follow up A 7 B 14 (I year: A 182; B 186)

Inclusion: >18 yrs, ≥Stage 2  symptomatic cystocele POP-Q

Exclusion: previous cancer of any pelvic organ, systemic glucocorticoid treatment, insulin-treated diabetes, an inability to participate or to provide consent, or need concomitant surgery.


InterventionsA (182): anterior colporrhaphy slow absorption monofilament thread, sham skin markings, excessive trimming vagina discouraged

B (191): Gynecare transvaginal anterior mesh (Prolift), absorbable sutures, excessive vaginal trimming discouraged, catheter care discretion surgeon

 


OutcomesPrimary outcome: composite score Ba <-1 and no symptoms on prolapse Q16 UDI

Secondary outcomes: Ba<-1 on POPq: Q16 -ve: adverse events, UDI and sexual function

Failure rate composite subjective and objective: A 114/174 (65%); B 69/176 (39%)

Subjective failure: A 64/174; B 44/179

Objective failure anterior wall ≥Stage 2: A 96/183; B 33/186

Operating time (min, SD): A 33.5(10.5); B 52.6 (16.5)

Blood loss (ml): A 35 (35); B 85 (163)

Blood loss>500mls: A 0; B 5

Inpatient days: A 1.6(1.1); B 1.8(1.2)

Cystotomy ( bladder perforation at surgery) A 1; B 7

Genital pain: A 1/174; B 5/186

Surgery prolapse: A 1; B 0

De novo SUI: A 11/176; B 22/179

De novo dyspareunia: A2/101; B 8/110

Point C and Point D significantly different post op between the groups:

median point C: A -6 (-9 to 7); B -6(-10 to 6)

median point D: A -7(-12 to -2); B -7.5(-12 to -1)

No difference between the groups postoperatively with UDI and PISQ-12

UDI-S (stress symptoms, mean SD): A 17.7 (13.9-21.4); B 24.2 (20.5-28)

UDI-O (obstructive symptoms, mean SD): A 12.3 (10.3-14.3); B 8.7 (6.7-10.7)

Surgery SUI: A 0; B 5

Mesh exposure (Personnel communication) A 0; B 21/183

Surgery mesh exposure: A 0; B 6


NotesFindings

Anterior mesh decreases the recurrence rate on examination and subjectively at 1 year

mesh surgery has longer operating time, greater blood loss, greater number with more than 500mls EBL, greater number cystotomies, greater number difficulty emptying bladder and inguinal pain  in early post phase. No difference in reoperation rate for prolapse seen 1 year( i in AC Gp A ) whereas reoperation rate higher in mesh group for SUI,  and mesh exposure and possible higher rate de novo dyspareunia.

The authors have not commented on sig difference between Point C and D between the groups. Some uncertainty surrounds veracity of POPQ measurements and how data was cleaned. Prior to surgery all symptomatic POP whereas 15% in each group reported asymptomatic

Very difficult to understand how women with large POP in all compartments i.e. C and D +6 were not offered surgery other than anterior compartment or meets exclusion criteria of not requiring surgery other than anterior compartment prolapse

(1) Subgroup analysis I: Ek et reported on urodynamic evaluation pre and two months post-surgery (A 27 women having anterior colporrhaphy and B 22 women having polypropylene mesh Prolift).

Objective de novo stress urinary incontinence was significantly less common: A 2/25; B 7/22

The maximum urethral closure pressure (MUCP) did not change significantly following intervention A, however in group B it reduced significantly from 44(6-69) preop to 29.5(14-79) postop in B.

(2) Subgroup analysis II:

CLINICAL EFFICACY OF A TROCAR GUIDED MESH KIT FOR THE REPAIR OF ANTERIOR LATERAL DEFECTS

preop A 45 B 61

persistent lateral defect 1 year: A 12/37; B 1/44

1 year stage Aa/Ba ≥ 0: A 18/43; B 4/60

In this abstract it is unclear why 6 in A and 14 in B: examined but no comment on lateral defects


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Low risksecure concealment with remote computer

Blinding of participants and personnel (performance bias)
All outcomes
Low riskpatients blinded (sham skin markings)

Blinding of outcome assessment (detection bias)
All outcomes
High riskreviewers surgeon 1/3, non-surgeon 2/3

participant-completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskpatient flow accounted for completely in both groups

Other biasHigh riskfunded Karolinska institute and Ethicon: conflict of interest statements of members of Nordic transvaginal mesh group who were reviewers of surgery were not reported

Benson 1996

MethodsSingle centre RCT for uterine or vault prolapse
Number table held by non-surgical co-author
Follow up A+B 2.5 years


Participants101 randomised
13 withdrawals (10 did not want surgery, 3 in A wanted vaginal surgery)
88 analysed
8 lost to follow up
Inclusion: cervix to or beyond hymen, vaginal vault inversion >50% length and anterior wall to or beyond introitus
Exclusion: uterus >12 weeks, adnexal mass, short vagina, central cystocele, >2 abdominal surgeries, obesity, prior inflammatory bowel or pelvic disease


InterventionsA (40): abdominal group: sacral colpopexy (mesh not specified), paravaginal repair, Halban, posterior vaginal wall repair with colposuspension or sling for stress urinary incontinence, non standardised continence surgery
B (48): vaginal group: bilateral sacrospinous colpopexy, vaginal paravaginal repair, McCall culdoplasty, needle suspension or sling; permanent sutures


OutcomesOptimal: asymptomatic vaginal apex > levator plate: no vaginal tissue beyond the hymen A: 22/38, B: 12/42
Satisfactory: asymptomatic for prolapse and prolapse improved from preoperative:
Symptomatic: prolapse apex descent >50% of its length or vaginal tissue beyond hymen
Incontinence A: 10/38, B: 16/42
Dyspareunia A: 0/15, B: 15/26
Peri-operative outcome:
Febrile: A 8% /38, B 4% /42
Hospital stay: A 5.4, B 5.1 days
Incontinence: A 23% /38, B 44% /42
Cost: Hospital charge: A US$8048, B US$6537
Further prolapse surgery: A 6, B 14
Further continence surgery: A 1, B 5


NotesAfter interim analysis study ceased early.
Satisfactory randomisation 63% vaginal group underwent continence surgery as compared to 40% abdominal group: 21% slings vaginal group as compared to 5% abdominal group suggesting unequal randomisation.
Women with a cystocele to the introitus postoperatively were considered to have optimal outcome when this was also part of inclusion criteria.
Objective outcome not reported
No stratification
No blinding
Standardised surgery, but continence surgery not standardised
No intention to treat
No CONSORT statement
No validated questionnaires
No quality of life measures.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskrandomisation table held by non-surgeon

Allocation concealment (selection bias)Unclear riskno data

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskno data

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskno data

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskno data

Other biasUnclear riskno data

Borstad 2010

MethodsRCT comparing prolapse surgery with TVT and prolapse surgery with delayed TVT at 3 months for women with POP and SUI

No CONSORT statement

Power calculation: 70 in each arm

randomisation process and allocation concealment adequately described

neither assessor or patients blinded

Intention-to-treat analysis: yes


ParticipantsInclusion criteria: non-consecutive women awaiting prolapse surgery with symptomatic and objective ( provocation 300mls) SUI or occult SUI ( SUI with pessary in position),

Exclusion criteria not specified

Randomised 194 (A 99; B 95)

Lost to follow up A 5; B 8

Analysed A 94; B 87


InterventionsA (94): unspecified prolapse surgery without TVT (53 women underwent TVT at 3 months following initial surgery if required)

B (87): unspecified prolapse surgery plus TVT


OutcomesObjective success (no symptoms SUI or urethal leakage on examination): A 72/94 (77%); B 83/87 (95%) at 3 months

New incontinence operation at 3 months: A 53/94; 0/87


Notesin gp A 41 women elected not to have subsequent TVT at 3/12: 14 of these had some symptoms and not stated how many of these wished they had TVT at initial procedure

Conclusion: it is difficult not to offer patients with pre-existing SUI continence surgery at time of vaginal prolapse surgery


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPC generated randomisation

Allocation concealment (selection bias)Low riskRandomised, allocation concealment appropriate

Blinding of participants and personnel (performance bias)
All outcomes
High risknon-blinded

Blinding of outcome assessment (detection bias)
All outcomes
High risknon-blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskclear assessment of patients

Other biasUnclear riskstated no authors conflict of interest, funding not stated

Braun 2007 abstract

MethodsSingle centre RCT comparing abdominal and vaginal routs for surgically treating central compartment prolapse

No CONSORT statement

No power calculation

No intention-to-treat analysis

No data on type of randomisation, blinding strategy or allocation concealment

No definition of cure or failure

Follow up 33 months (20-41) both arms

Prolapse assessment: POP-Q


ParticipantsInclusion: POP-Q Stage 3-4 prolapse

Exclusion: not specified

Randomised: 47

Analysed: 47


InterventionsA (23): TAH ± BSO + abdominal (open) sacral colpopexy

B (24): vaginal hysterectomy + anterior & posterior colporrhaphy + Mayo McCall stitch

Materials used:

A: vypro mesh (combined absorbable - non-absorbable); prolene (non-absorbable) sutures to both sacrum and vagina

B: delayed absorbable (PDS) sutures


OutcomesMean operating time: Gp A: 140 min (100-240); Gp B: 90 min (50-130)

Mean days in hospital: Gp A: 3.8; Gp B: 2

Objective failure: A: 0/23; B: 2/24 (1 anterior and 1 vault)

Further prolapse surgery: A: 0/23; B: 1/24

Total complication rate: A: 3/23 (13%); B: 0/24

Specific complications: A: haematoma 1/23, mesh erosion: 1/23, incisional hernia: 1/23


NotesA quantitative definition for success or failure is not provided. The mean operating time, length of hospitalisation and rates of complications were higher in the sacral colpopexy group but in the absence of statistical comparisons to support these results, one cannot comment on their significance. 


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear risknot stated

Brubaker 2008

MethodsRCT (computer generated block stratification for surgeon and paravaginal repair), sealed envelopes opened at time of surgery after anaesthetic was administered)
7 Site: Multi-centre study in USA
Follow up: 3 months (data at 1 year for 231 women) 2 year data

interviewers and examiners blinded

imputation of 2-yr outcome data (those re-operated included outcome related to worse of score prior to 2nd intervention or after subsequent intervention)


Participants322 women. CONSORT statement

Inclusion criteria: POP-Q stage 2-4 prolapse (Aa must be -1 or worse) and stress continent based on responses of ‘never’ or ‘rarely’ to 6 of the 9 SUI questions of MESA. Despite these criteria, preoperatively 19.2% participants had SUI defined by PFDI, 10% had bothersome stress urinary incontinence (PFDI questionnaire) and 39% had a positive stress test with or without prolapse reduction prior to intervention. From table 2 of the 3 month data it appears these participants were equally distributed between the groups.
Exclusion criteria: Immobile urethrovesical junction, pregnancy, anticipated move away after surgery
Groups were comparable at baseline on age, race, ethnic group, marital status, education, parity, method of delivery, distribution of women with positive stress test, OAB, prior hysterectomy continence and prolapse surgery.

Surgeons were unaware of urodynamic findings including urodynamic stress incontinence or occult stress incontinence with or without the prolapse reduced


InterventionsA (157): abdominal sacral colpopexy with Burch colposuspension
B (165): abdominal sacral colpopexy without Burch colposuspension (control group)
Compliance: women treated according to randomised groups: A, 154/157; B, 164/165

concomitant surgery paravaginal repair A 31/157 20% Gp B 34/165 20.6%

hysterectomy GP A 29%: Gp B 28%

standardised surgery for colposuspension: not standardised paravaginal repair or sacral colpopexy (17% biological grafts, 43% Mersilene and 39% polypropylene and minimal use of PFTE (Gore-tex) (6%).

While surgery was standardised for colposuspension neither the paravaginal repair nor sacral colpopexy was standardised with variation in use of suture type and graft materials: 17% biological grafts, 43% Mersilene 39% polypropylene 6% Gore-tex. No data on further performed surgeries is provided in the publication.


OutcomesAt 3 months: SUI composite end point defined as any of the following present:

1. Symptoms, as defined by a “yes” response to any of three questions in the PFDI stress incontinence subscale assessing leakage with coughing, sneezing, or laughing; physical exercise; and lifting or bending over

2. Stress incontinence during a standardized stress test at maximum bladder capacity or 300 mL, whichever was less

3. Any treatment for stress incontinence after the study surgery

Composite SUI outcome at 3 months: A, 35/156; B, 67/164; 1 year: A, 42/155; B, 42/155; 24 months: A,47/147, B,70/155
Composite OAB outcome at 3 months: A, 50/156; B, 59/164; 12 months: A, 51/155, B, 66/161; 24 months: A, 47/147, B, 69/155
Urge urinary incontinence at 3 months: A, 10/143; B, 18/151; 12 months: A, 9/155, B, 17/158; 24 months: A, 10/147, B, 19/155
Operation time (N, mean min, SD): A, 157, 190 (55); B, 165, 170 (60)
Blood loss (N, mean ml, SD): A, 157, 265 (242); B, 165, 192 (125)
Cumulative adverse effects at 24 months: A, 56/153; B, 64/158
Serious adverse effects: A, 7/157; B, 5/165

At 2 years:

Two year results were reported on Group A (n = 157) and B (n = 165)

SUI symptoms (PFDI+ve): A 38/147, B 63/155

+ve cough stress test: A 11/116, B 9/134

Further surgery for SUI: A 19/147, B 31/155

Bothersome SUI: A 17/147, B 39/155

Bothersome UI: A 10/47, B 19/155

POP-Q outcomes, mean (SD): point C (cervix): A -8.0±1.5, B -8.2± 1.3

Ba (anterior): A -2.2±0.9, B -1.8±1.1

Bp (posterior): A -2.0±0.9, B -2.3±0,8

stage 0 24/117, 23/132; stage 1 43/117, 51/132; stage 2 46/117, 57/132; stage 3 4/117, 1/132


NotesStudy terminated after 322 women had been randomised because of significant differences in UI outcomes
Results not reported separately according to whether concomitant hysterectomy performed
Women remained in allocated groups for analysis (ITT) but analysis based on end-point data actually available

Further data were made available in a new report depending upon status of occult stress incontinence (Visco 2008). The prolapse reduction during preoperative stress testing was performed with 5 different methods (swab, manual, speculum, pessary or forceps) with each women undergoing two types of prolapse reduction. Data from all prolapse reductions (2 for each patient) were reported as a total at 3 months only.  Visco concluded that none of the techniques to demonstrate occult urinary incontinence were able to predict which women would become incontinent or not with or without concomitant continence surgery, although women who did have occult incontinence were more likely to be incontinent afterwards regardless of randomised allocation.  Data from all prolapse reductions (two for each patient) were reported as a total and in analysing the post intervention continence status of women who did and did not have occult stress incontinence pre-operatively a decision was made to half the reported total numbers for the analysis.

Stress continence at baseline was defined based on responses of ‘never’ or ‘rarely’ to six of the nine SUI questions on the MESA questionnaire (medical, epidemiological and social aspects of aging questionnaire). Preoperatively 19% of the participants had SUI defined by the PFDI (Pelvic Floor Distress Inventory), 10% had bothersome stress urinary incontinence according to the PFDI and 39% had a positive stress test with or without prolapse reduction prior to surgery.

Different and complicated definitions were used to categorise stress continence prior to and after the interventions making it more difficult to be classified as stress continent post interventions than prior to the intervention (see included studies tables). 39% classified as stress continent prior to surgery would have been classified as stress incontinent using the post-intervention definition.

The use of imputation in the two year results is to be applauded by the authors. The process utilised ensures that in women undergoing further continence surgery that the continence status prior to the second intervention or after the surgical intervention outcomes, whichever is worse, is included in the final outcome data.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPC generated

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Low riskblinded patients

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded patients

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata accounted for equally

Other biasUnclear riskfunded competitive research grants

Bump 1996

MethodsDual centre RCT: needle suspension or plication of urethrovesical junction endopelvic fascia for cystocele and potential stress incontinence
Computer generated randomisation, blocks of 4 to 6
Follow up A+B 2.9 years


Participants32 women
Withdrawals: 0
Inclusion: stage 3 or 4 anterior vaginal wall prolapse and bladder neck hypermobility
Lost to follow up: 4


InterventionsA (14): needle suspension according to Muzsnai with non-absorbable sutures
B (15): plication of urethrovesical junction endopelvic fascia according to Hurt with non-absorbable suture


OutcomesDefinition of cure: no stress urinary incontinence, no overactive bladder symptoms, no voiding dysfunction
Postoperative urodynamic stress incontinence that was not present preoperatively: A 2/14, B 1/15
New overactive bladder symptoms: A 2/14, B 1/15
Describes site specific pelvic organ prolapse


NotesNo blinding
No stratification
No intention to treat
No CONSORT
Potential stress incontinence was identified in 20/29 preoperatively
The definition of potential stress urinary incontinence included a positive barrier test or pressure transmission ratio of <90% for proximal 3/4 of the urethra
Validated questionnaires.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Unclear riskNS

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNS

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskvalidated questionnaires assessments not stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNS

Other biasUnclear risknot stated

Carey 2009

MethodsSingle centre RCT

CONSORT no

Randomisation computer generated

Allocation concealment N/S

subjects, surgeons and reviewers not blinded

12 months follow up


ParticipantsInclusion criteria: women recommended vaginal surgery for anterior and posterior compartment with ≥ grade 2 prolapse

Exclusion criteria: only requiring anterior or posterior compartment surgery, apical prolapse beyond the hymen or those requiring abdominal mesh surgery

Randomised: 139 (A: 70, B: 69) 10 women breached study protocol and 11 more recruited. All were analysed

Lost to follow up: A: 6, B 9

Analysed 12 months :  A 63, B 61


InterventionsA (70): traditional anterior and posterior fascial plication using polydioxanone sutures

B (69): anterior and posterior repair with Gynemesh PS augmentation


OutcomesDefinition of cure: less than stage 2 prolapse at all sites

Objective failure stage 2 or greater POP-Q at any site: A 21/61, 34%, B 12/63, 18% P=0.07

Subjective failure (not satisfied with surgery, VAS <80): A 12/63 19%, B 14/59 9% p=0.12

Dyspareunia A 13/33 39% B 12/30 (40%)

De novo dyspareunia A 5/12 42%, B 5/18 28% p=.46

Mesh erosion: A 0, B 4/63 (6.5%) 3 of 4 surgery

subsequent prolapse surgery Gp A 2 Gp B 0


NotesPre-operatively there was significant limitation in data recording with prior prolapse surgery and dyspareunia rate being recorded in only 51 of 70 recruited in Gp A. With both the preoperative dyspareunia rate and prior prolapse surgery approaching a statistically  significant level missing such rudimentary preoperative data is disappointing.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)High riskno information on allocation concealment. significant pre-operative data missing as above

Blinding of participants and personnel (performance bias)
All outcomes
High riskno blinding

Blinding of outcome assessment (detection bias)
All outcomes
High riskno blinding

Incomplete outcome data (attrition bias)
All outcomes
Low riskclear follow up of patients both groups

Other biasHigh riskfunding not stated: authors conflict of interest financial agreement with Ethicon manufacturer of product evaluated in study

Colombo 1996

MethodsSingle centre RCT (computer generated, unclear if allocation concealed)
Cystopexy or cystopexy and pubo-urethral ligament plication for cystocele
Follow up: A 2.6 years, B 2.9 years


Participants107 randomised
Lost to follow up: 4, 1 died
102 analysed
Inclusion: cystocele grade 2 or more
Exclusion: positive stress test with or without prolapse reduced, overactive bladder symptoms, MUCP <30, previous incontinence surgery


InterventionsA (52): cystopexy alone: interrupted non-absorbable sutures of fascia
B (50): cystopexy and pubo-urethral ligament plication according to Hurt with absorbable suture
McCall culdoplasty and posterior repair in all women


OutcomesObjective cure of cystocele less than grade 2: A: 50/52, B: 48/50
Reduction in voiding symptoms:
Successful prevention stress urinary incontinence: A: 48/52, B 46/50
Dyspareunia: A 2/24, B 13/23
New postoperative overactive bladder symptoms
Voiding dysfunction
Days in hospital


NotesNo blinding
No intention to treat
Power calculation post hoc
No CONSORT
No validated symptom or QOL questionnaire
Informed consent not required before randomisation
Surgery standardised
Who reviewed outcomes was unclear.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear risknot stated

Colombo 1997

MethodsSingle centre RCT (computer generated, allocation concealment unclear)
Follow up: A 6.3 years, B 6.7 years


Participants109 randomised
109 analysed for 5 years postoperatively
9 died 3-7 years postoperatively
Inclusion: positive stress test with or without prolapse reduced, cystourethrocele > grade 2
Exclusion: negative stress test, overactive bladder symptoms, MUCP <30, previous incontinence surgery


InterventionsA (55): Cystopexy with interrupted non-absorbable sutures of fascia pubo-urethral ligament plication with absorbable sutures
B (54): Pereyra with non-absorbable sutures
McCall culdoplasty and posterior colporrhaphy in all women


OutcomesObjective cure of cystocele less than grade 2: A 55/55, B 52/54
Subjective cure SUI: A 43/55, B 48/54
Objective cure SUI: A 24/55, B 37/54
Objective cure of occult SUI: A 20/40, B 25/43
New post-operative overactive bladder symptoms, voiding dysfunction, days in hospital


NotesNo blinding
No intention to treat
Power calculation performed post hoc
No CONSORT
No validated symptom or quality of life measures
Informed consent not required before randomisation
Surgery standardised
Who reviewed outcomes unclear.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear risknot stated

Colombo 2000

MethodsSingle centre RCT (computer generated open number list )
Burch or anterior repair for pelvic organ prolapse and stress urinary incontinence
PC-open list
Follow up: A 14.2, B 13.9 years


Participants71 randomised
Lost to follow up: 3 (A 2, B 1)
68 analysed
Inclusion: USI, cystocele >2 or 3, swab test >30%
Exclusion: detrusor overactivity, previous pelvic floor surgery, high risk for abdominal operation


InterventionsA (35): Burch group: total abdominal hysterectomy and vault to uterosacral ligament, Moschcowitz, Burch with 3-4 Ethibond
B (33): anterior colporrhaphy: vaginal hysterectomy, Pouch of Douglas obliteration and anchoring of vaginal cuff to uterosacral ligament, catgut plication


OutcomesDefinition of cure: no subjective stress urinary incontinence, or no positive stress test
Objective cure cystocele: A 23/35, B 32/33
Subjective cure stress urinary incontinence: A 30/35, B 17/32
Objective cure stress urinary incontinence: A 26/35, B 14/32
Overactive bladder symptoms, voiding, dyspareunia
Total vaginal length: A 7.9 cm, B 4.7 cm


NotesNo blinding
No intention to treat
No CONSORT
No stratification
No power calculation
No validated symptom or QOL questionnaire
Surgery standardised.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)High riskC - inadequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNS

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNS

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNS

Other biasUnclear riskNS

Costantini 2007

MethodsSingle centre RCT

Randomisation not stated

Allocation concealment not stated

Blinding of outcome assessors not stated

No CONSORT


Participants6 women

Inclusion: continent women (women with negative stress test before and after prolapse reduction, no preoperative symptoms of urinary incontinence, negative symptom questionnaire and no leakage during urodynamics) with 'severe' uterovaginal and vault prolapse (not clearly defined)

Exclusion: N/S

66 randomised

66 analysed


InterventionsA (32): sacral colpopexy (open)

B (34): sacral colpopexy + Burch (open)

concomitant surgeries: abdominal hysterectomy


OutcomesLength of F/U: A 38±19 mo (range 15-71); B 42±18 mo (range 12-74)

Overall de novo incontinence: A 3/32 (9%); B 12/34 (35%) p< 0.05

De novo stress incontinence: A 1/32 (3%); B 9/34 (27%)


NotesPrimary continence assessments were based on a non-defined stress test, and symptoms from the UDI questionnaire. Urinary incontinence was clinically classified “on the basis of the ICS definition and graded on the Ingelman Sunderberg scale”.  Pre-operative UDI scores were given but no postoperative UDI scores were available.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot stated

Other biasUnclear riskno conflict of interest statement or funding statement

Costantini 2008

MethodsSingle site RCT

Blinded assessors

Intention to treat NS

Power calculation adequate

Sample size 47


ParticipantsCONSORT statement: yes

Inclusion: women age 18-75, POP>St. 2 (BW and POPQ), urinary incontinence defined by ICS

Exclusion: uterine fibroids, uterine/cervical malignancy, active PID, allergy to synthetic graft/suture materials, pregnancy/lactation, significant illnesses, inability to provide informed consent or comply with study protocol 

47 randomised A 23; B 24

No loss to follow up

Distribution of POP between groups not clear: 24 uterovaginal, 13 vault, 8 cystocele and 2 cystocele and rectocele


InterventionsA (23): sacral colpopexy 17, sacral hysteropexy 6, no colposuspension

B (24): sacral colpopexy + Burch 14, sacral hysteropexy + Burch 10

Pre-operatively incontinence defined by urodynamics: 13 USI, 30 mixed, 4 occult (incontinence with coughing or Valsalva manoeuvre with the prolapse reduced). Distribution of patients with prolapse and incontinence pre-operatively between the groups is unclear


OutcomesPrimary incontinence outcome: combination of bladder diary, number of pads and stress test without clear definition: A 9/23, B 13/24 (P=0.46)

Secondary outcomes included quality of life (IIQ and UDI) VAS and subjective symptoms

Median pads/day (range): A pre 1 (0–5) post 0 (0–3); B pre 1 (0–5) post 1 (0–3)

Median IIQ score(range): A pre18 (1–53) post 2 (0–17); B pre 16 (3–33) post 2 (0–11) (P=0.33)
Median UDI score (range): A pre 16 (0–45) post 3 (0–10); B 16 pre (6–45) post 3 (0–10) (P=0.77)
Median VAS* satisfaction score (range): A 9 (3–10); B 8 (4–10)

POP was a primary outcome without clear definition failure: no differences were detected in anatomical outcome (POP-Q measurements given in paper for 7 POP-Q measurements)


NotesThe authors’ conclusion that colposuspension at time of sacral colpopexy has little positive benefit seems valid. There are methodological problems with this paper, including lack of clear and equal distribution of prolapse grading and incontinence between the groups pre-operatively, inconsistency of pre and post-operative incontinence classifications (urodynamics pre-operatively and symptoms post-operatively) and lack of definition of success of prolapse grading and data relating to peri-operative parameters and complications.        


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded assessors

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskunclear

Other biasUnclear riskCOI or funding statement not included

Culligan 2005

MethodsSingle centre RCT
(computed generated, blocked, opaque envelopes, double blind)
Fascia lata versus polypropylene mesh for sacral colpopexy
Follow up: 1 year


Participants100 randomised
Lost to follow up: 11 (A 2, B 9)
Inclusion: post-hysterectomy vault prolapse
Groups comparable at baseline on age, weight, height, parity, incontinence severity, POP-Q measurements, prolapse stage, previous prolapse or incontinence surgery (A 19/46, B 24/54)
Randomised group compared with women who declined randomisation (101 women), no statistically significant differences found


InterventionsA (46): abdominal sacral colpopexy with cadaveric fascia lata graft (Tutoplast) attached with Goretex to anterior and posterior vaginal wall and to S1-S2, covered with peritoneum
B (54): abdominal sacral colpopexy as above, using polypropylene mesh (Trelex)
Concomitant surgery: TVT, paravaginal and rectocele repair; conditions not defined


OutcomesDefinition of failure: POP-Q stage 2 or greater at any site: A 14/44, B 4/45
Recurrent vault prolapse at point C: A 0/44, B 0/45
Blood loss N, mean ml (SD): A 46, 265 (261), B 54, 47 (148)
Operating time N, mean min (SD): A 46, 233 (7), B 54, 227 (63)
Ileus: A 0/46, B 2/54
Adverse effects: fever: A 2/46, B 2/54; wound breakdown: A 5/46, B 8/54; graft erosion: A 0/46, B 2/54
Total adverse effects: A 7/46, B 12/54

5 year update

Objective success

Gp A 18/29 Gp B 27/29

Clinical definition Gp A 26/29 Gp B 28/29


Notes4 women randomised to fascia (A) actually received mesh (B) and were analysed in the mesh group, therefore NOT true ITT.
One single blinded examiner
No ITT
Only mean values of POPQ given for sites apart from point C
No analysis of questionnaires, bladder, bowel and sexual function.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Low riskpatients blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded assessor nurse

Incomplete outcome data (attrition bias)
All outcomes
Unclear risklow risk

Other biasUnclear riskauthors had COI with Bard whose mesh was assessed. Funding study not stated

De Ridder 2004 abstract

MethodsRCT (unclear randomisation and concealment)
Pelvicol versus Vicryl for stage III cystocele repair
Follow up: 25/26 months


Participants134 included
A 65, B 69
Inclusion: stage III cystocele


InterventionsA (65): Raz 4 defect cystocele repair reinforced with porcine dermis overlay (Pelvicol)
B (69): as above, reinforced with Vicryl
Concomitant surgery: vaginal hysterectomy and rectocele repair


OutcomesPrimary outcome: recurrence of cystocele stage II: A 6/63, B 19/62 (p=.002)
Number having repeat prolapse surgery: A 3/63, B 9/62
No differences in questionnaires


NotesAbstract, limited information though requested
No subjective outcome, no analysis of bladder, bowel and sexual function.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNS

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNS

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNS

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNS

Other biasUnclear riskNS

de Tayrac 2008

MethodsMulicentre RCT comparing Infracoccygeal sacropexy and sacrospinous suspension for uterine or vaginal vault prolapse

No CONSORT statement

Power calculation: yes, 77 required in each arm. Recruitment stopped after change in mesh material (multi-filament mesh replaced by monofilament)

No intention-to-treat analysis

No data on type of randomisation, blinding strategy or allocation concealment

No definition of cure or failure

Mean follow up 16.8 months (range 1.5 - 32) both arms

Prolapse assessment: POP-Q

Validated questionnaires: PFDI, PFIQ, PISQ-12, French version


ParticipantsInclusion: symptomatic uterine or vaginal vault prolapse (stage 2 or higher)

Exclusion: isolated cystocele, stage 1 prolapse, rectal prolapse, and intestinal inflammatory disease

49 randomised

4 lost to follow up

45 analysed


InterventionsA (21): infracoccygeal sacropexy (multi-filament Polypropylene tape, posterior IVS)

B (24): sacrospinous suspension

Concomitant surgery: cystocele repair, posterior repair, hysterectomy, suburethral tape. Types of repair and indications for repair were not described.


OutcomesPrimary outcome measure: post-operative day 1 pain assessed by a VAS

Secondary outcome measures: peri-operative data, quality of life, anatomical results and erosion rates

Anatomical failure (not defined): A 1/21 (4.8%); B 0/24; p=0.94

Post-op uterine/vault prolapse (stage>1): A 1/21 (4.8%); B 0/24; p=0.94

Post-op cystocele (stage>1): A 1/21 (4.8%); B 6/24 (25%); p=0.14

Post-op rectocele (stage>1): A 0/21; B 1/24 (4.2%); p=0.94

Further prolapse surgery: A 2/21 (9.5%); B 2/24 (8.3%)

Day 1 post-op pain (VAS 0 to 10, 0=no pain): A 1.3+/-1.6; B 3.2+/-2.7; p=0.01

Operating time mean (min): A 13.2+/-5.2; B 20.0+/-8.1; p=0.002

Days in hospital mean: A 4.9+/-1.8; B 3.9+/-1.2; p=0.06

Patients' satisfaction: A 18/21 (86%); B 19/24 (79%)


NotesPower calculations were unusually based on the parameter of day 1 pain scores and necessitated 77 women in each group.

While the pain on day 1 VAS was significantly greater (p=0.01) in the sacrospinous group, no differences were seen on days 0, 2 or at follow up.

PISQ-12, PFDI and PFIQ scores were not significantly different between groups but absolute values were not given for the latter two.

The authors concluded the posterior IVS was equivalent to the sacrospinous suspension with a decreased rate of post-operative pain and cystocele recurrence. The higher recurrent cystocele rate was non-statistically significant and difficult to evaluate given the lack of documentation of anterior compartment surgery. The conclusion regarding decreased pain is also misleading as it only relates to day 1 scores and not supported by data on days 0, 2 and post-operative follow up.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskparticipant completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskCOI or funding unstated

Dietz 2010

MethodsRCT

1 yr review

Inclusion: stage 2 or greater uterine prolapse

CONSORT

Not blinded, sample size calculation bases upon recovery time

Randomisation and concealment appropriate.

Concomitant surgery anterior and posterior repair, TVT if required


Participants71 randomised Gp A 34 Gp B 37

Withdrew 3, 2

Surgery 31, 35

Lost to follow up 0 2

Analysed 31, 33 the article results quote 34 SS hysteropexy group

Groups were comparable at baseline


InterventionsA (31) vaginal hysterectomy with uterosacral suspension

B (34) vaginal sacrospinous hysteropexy with uterine preservation


OutcomesPOPQ stage 2 or greater objective failure:

apical (vault / uterine) A 1/31, B 7/34

Ba (anterior, cystocele) A 20/31, B 17/34

Bp (posterior, rectocele) A 9/31, B 6/34

hospital stay median A 4 days, B 3 days (P=0.03)

further prolapse surgery A 2/31, B 4/34

days to return to activities of daily life A 33±21, B 34±13

days to return to work A 66±34, B 43±21.

No differences were reported in domain scores on quality of life and urogenital symptoms UDQ and IIQ between the two procedures one year after the surgery. Functional outcomes and quality of life did not differ between the procedures. 

TVL cm Gp A 7.3( 1.5) Gp B 8.8(1.3)

point D (behind cervix or vault) Gp A -5.7( 1.9) Gp B -7.4(2.6)


NotesThe authors concluded that more recurrent apical prolapses were found after the sacrospinous hysteropexy as compared to vaginal hysterectomy at one year. Sacrospinous hysteropexy quicker return to work and longer vagina than hysterectomy group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskvia research nurse mail

Blinding of participants and personnel (performance bias)
All outcomes
High riskno

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskparticipant-completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Low riskreported last data carried forward and worse case scenario

Other biasUnclear riskCOI none: no statement on funding

Farid 2010

Methodsmulti-surgeon dual centre RCT

randomisation: nurse taking card from envelope

allocation concealment poorly described

reviewers blinded


Participantsparticipants not described re blinding

inclusion criteria a rectocele larger than 2 cm with one or more of the following symptoms: need for digital manipulation during
defecation, sense of incomplete evacuation, excessive straining, or sexual dyspareunia.

exclusion criteria: Patients with recurrent rectocele, rectal intussusception, anismus, diabetes, previous anal surgery, systemic steroid treatment, connective
tissue disease, slow-transit constipation (diagnosed by The SITZMARKS radiopaque marker if it appear in X-ray of
the abdomen after 5 days), compromised anal sphincter function (diagnosed by fecal soiling or RAP\40), or
abnormal thyroid function were excluded from the study.


InterventionsGp A (n=16) transperineal repair (3.0 vicryl) with levatorplasty (0.0 vicryl)

Gp B (n=16) transperineal repair alone

gp C (n=16) transanal approach 2.0 vicryl ) (Delorme procedure)


Outcomes6 month assessment

pre and post patient completed modified obstructed defecation syndrome patient questionnaire

pre and post anal manometry

rectocele size on defecography A 0.94±0.74 B 0.94±0.75 C 2.08±1.58

functional score A 3.8±1.7 B 7.7±2.5 C 12.8±8.9

no cases de novo dyspareunia

wound infection transperineal groups 3/32, 9%


Notesthe authors conclude that transperineal repair is superior to transanal repair in structural and functional outcome


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskunclear, nurse taking card from envelope

Allocation concealment (selection bias)Low riskopaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskexaminers blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskall patients accounted for

Other biasUnclear risknot stated

Feldner 2010

MethodsA single centre RCT

randomisation and allocation concealment was described

evaluated 1 year after anterior colporrhaphy (AC) as compared to small intestine submocosa graft

blinded reviewers


ParticipantsInclusion criteria was women wth Point Ba≥-1

and those with hypertension, prior radiation, pelvic sepsis, diabetes and chronic illness were excluded

concomitant surgery allowed including vaginal hysterectomy if greater than stage 2 uterine prolapse.


InterventionsGp A (27) anterior colporrhaphy with interrupted 0 vicryl sutures GP B (29) a non-cross linked xenograft porcine small intestine submucosa 7x10cm with dissection to suprapubic arch fixed with 0 prolene x3 each side


Outcomesoperating time minutes GP A 30.0±19.4mins as compared to 46.3±16.1mins in Gp B (SIS) P=.02

Objective failure rate( defined as point Ba ≥ -1) Gp A 9/27 Gp B 4/29

mesh exposure nil both groups

total complications Gp a 9/27 less than Gp B 20/29 P=.01

dyspareunia post intervention A 4/27 B 5/20

reoperations A 0 B 0

P-QOL improved post-operatively Gp A and B postoperatively with no significant difference between the groups at 12 months


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskallocation concealment appropriate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded reviewers and patient-completed validated questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Low riskdata well described

Other biasLow riskno COI and no external funding

Gandhi 2005

MethodsSingle centre RCT (computer generated, opaque envelopes, adequate concealment)
Anterior colporrhaphy with and without fascia lata for primary or recurrent anterior vaginal wall prolapse


Participants162 signed consent form
154 randomised
A 76, B 78
Loss to follow up 2 in B but in results 78 and 77 analysed
Inclusion: anterior vaginal wall prolapse to hymen or beyond on straining; >18 years of age; willing to comply with return visits
Concomitant surgery: vaginal hysterectomy in 49%/47%; sacrospinous fixation in 43%/42% (all cases with vaginal vault prolapse to mid-vagina or beyond); posterior repair in 99%/94%, Coopers' ligament sling in 67%/55%, mid-urethral sling 13%/10%
Enterocele: A 75%, B 73%
Baseline voiding dysfunction (slow stream): A 48/68, B 42/65


InterventionsA (76): "ultra-lateral" midline plication of anterior endopelvic connective tissue using Vicryl buttress sutures (as described by Weber 2001), plus additional cadaveric fascia lata patch (Tutoplast) anchored at the lateral limits of the colporrhaphy
B (78) as above without allograft


OutcomesDefinition of failure: recurrent stage II cystocele: A 16/76; B 23/78
Subjective failure (vaginal bulging): A 6/55, B 6/57 (note: the denominator is different to objective outcome)
Postoperative voiding dysfunction: A 21/72, B 28/76
Persistent voiding dysfunction: A 19/53, B 22/52
De novo voiding dysfunction: A 3/19, B 6/24


NotesUnclear patient numbers (disparity with loss to follow up)
Questionnaires not used in all patients.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskdata complete

Other biasUnclear riskno COI or funding statement

Guerette 2009

MethodsMulti-centre RCT

24 month follow up

randomisation computer generated

allocation concealment without blinding of patients or surgeon

not according consort


Participantsrandomised Gp A 47 Gp B 47

2 years Gp A 33 Gp B 26

examination A 27 B 17

Inclusion criteria was point Ba ≥ -1 and those with TVL<6cm, severe atrophy,  isolated paravaginal defect, allergic bovine material, prior vaginal implant surgery or with ulceration were excluded


InterventionsA (n=46): anterior colporrhaphy

B (n=44): anterior colporrhaphy with bovine pericardium collagen matrix graft reinforcement.


Outcomesfailure rate 2 years defined as point Ba ≥-1

A 10/27 B 4/17

reoperations prolapse A 10/27 B 4/17

de novo dyspareunia at 1 year A 1/20 B 0/17

Qol: UDI-6 and PISO-12 reported as improving both groups post intervention with no significant difference between the groups with numerical values not supplied


Notesunderpowered study with less than 50% completing 2 year review  


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskopaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes
High riskno blinding

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskno blinding assessors, patient completed questionnaire

Incomplete outcome data (attrition bias)
All outcomes
High riskequal losses in both groups only 50% at 2 year review

Other biasHigh riskextensive COI reported: study part funded Synovis life technology whose product was being evaluated Bovine pericardium

Halaska 2012

Methodsmulti-centre randomised trial

computer generated randomisation table

allocation concealment not defined

70% power to detect 20% difference in groups


Participantsincluded; central post-hysterectomy vault prolapse: POP-Q greater or equal Stage 2 POP

greater or equal excluded pelvic malignancy, <18 years, prior radiotherapy, those requiring hysterectomy

allocated group A 83 Gp B (TVM) 85

I year Gp A 72 Gp B 79

recurrence defined as stage 2 or greater POP-Q

not clear who performed assessments


InterventionstGp A (83) anterior repair( Sutures? type?) R sacrospinous colpopexy ( 2x non-absorbable sutures Nurolen) ±Posterior repair (approximation of levator muscles) and moderate excision of redundant vagina

gP B (85) Total prolift mesh secured with 2.0 PDS sutures

intervention performed by surgeons with greater than 20 cases experience of each type surgery


Outcomesrecurrence prolapse 1 year

Gp A 28/72 Gp B 13/79

mesh exposure Gp B 16/79 (20%) 10/79 (12.6%)surgery 6 resolved with local oestrogens

Bladder injury Gp A 1/73 Gp B3 (3.8%)

blood loss Gp A 110 (10-528ml range) and Gp B 120ml (10-814)

denovo SUI Gp A 18/72 ( 25%) Gp B 27/79 (35%)

denovo OAB Gp A 8/72 Gp B 8/79

dyspareunia Gp A 2/72 93.7%) Gp B 6/79 (8%)

Pelvic pain Gp A 3/72 5.5% Gp B 6/79 (8.1%)

reoperation prolapse Gp A 3/72 Gp B 1/79

No difference in Qol outcomes reported between th 2 groups including PISQ, UIQ, CRAIQ, POPIQ and results reported as mean and no standard deviation


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Unclear riskNS

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNS

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNS

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskall participants accounted for in flow study

Other biasLow riskfunded by grant from Czeck ministry health care, authors no COI

Hviid 2010

Methodssingle centre RCT

computer generated randomisation and allocation concealment was appropriate with sealed envelopes opened in operating room

reviews by non blinded surgeon

no concomitant surgery

80% power to detect 20% difference 5% type 1 error


Participantsinclusion criteria symptomatic prolapse Point Ba ≥ -1: and those with defects posterior or apical compartment, prior pelvic surgery, history collagen or endocrine disorders were excluded

allocated Gp A 31 Gp B 30

1 year A 26 Gp B 28


InterventionsA (31): 2.0 interrupted Vicryl plication

B (30): no plication, Pelvicol porcine dermis 4x7cm anchored with 2.0 Vicryl sutures

no concomitant surgery


Outcomesfailure rate defined as point Ba >-1: A 4/26; B 2/28

operating time minutes: A 23.9 ( 9.8) B 32 ( 8.6)

blood loss (ml): A 56 (27,2) B 70 (71)

recurrent POP surgery A 2 B 3

continence surgery A 1 B1

P-QOL improved both groups post-surgery with no difference between the groups


Notesirregularites exist: methods failure defined as e Ba ≥-1 results >-1

in table 2 Gp a range Ba 2-8 and states in table 3 that 4 had Stage 2 prolapse


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
High riskreviewers non blinded, participant-completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear risklost to follow up accounted for

Other biasUnclear riskno COI declared: no statment funding

Iglesia 2010

MethodsMulti-centre RCT

double blinded

power calculation included

randomisation computer generated stratified for presence uterine prolapse, allocation concealment, CONSORT guidelines met


Participants173 excluded variety reasons

Gp A 33 Gp B 32

lost to follow up A 0 B 0

prior to surgery all demographic details similar between the 2 groups: except Gp b lower POPDI-6 score than group A

Inclusion criteria  included    ≥21 yrs, grade 2-4 (POP-Q)  uterovaginal or vaginal prolapse who agreed to undergo vaginal surgery, available 12months review and can complete questionnaires.

Exclusion criteria included  multiple medical contraindications, short vagina, uterus >12weeks size,  desire future fertility and postpartum


InterventionsGp A uterosacral colpopexy with polytetrafluoroethylene sutures or sacrospinous colpopexy (Gortex sutures) and hysterectomy performed if uterus present.

Gp B: B if point C or D on POPq was ≥-3 apical suspension with Total vaginal mesh (prolift) and if Cor D was <-3 anterior Prolift utilised. No T incisions were performed and hysterectomy performed if uterus present.


Outcomesobjective failure rate 1 year ( any stage 2 or greater prolapse) Gp A 23/33 B 20/32

subjective failure A 3/33 B 1/26

reoperations prolapse A o B 3 2 sacral colpopexy and 1 iliococygeus fixation

mesh exposure A o B 5/32

surgery mesh exposure A 0 B 2

de novo dyspareunia A 3/14 1/11

transfused A 0 B 1

cystotomy ( bladder perforation) A 0 B 2

de novo USI A 3 B 6

No differences were seen between the groups in any of the validated outcome tools at 12 months including

SF-12 PCS, SF-12 MCS, PISQ, POPDI-6, CRADI-8, UDI-6, PFDI, UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, PGI-I, or PGI-S scores.


NotesThe ethics committee stopped the study prior to completion due to pre-determined  stopping criteria of mesh erosion rate of >15% being reached  with 65 of the desired sample size of 90 having undergone interventions.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskdouble blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskdouble blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskequal assessment groups

Other biasLow riskfunded American Urogynecology Society foundation and Medstar research; authors reported no conflict of interest

Jeng 2005

MethodsRCT (unclear randomisation and concealment)
Total vaginal hysterectomy versus transvaginal sacrospinous uterine suspension
Follow up: 6 months


Participants158 women
Dropouts: 0
Inclusion: age <50 years; Grade 2-3 uterine or cervical prolapse; sexually active
Exclusion: previous anterior or posterior vaginal wall repair, or oophorectomy
Groups comparable at baseline on age, parity, height, weight, partners' health status, sexual functioning


InterventionsA (80): transvaginal sacrospinous uterine suspension (without hysterectomy)
B (78): total vaginal hysterectomy
All operations done by one surgeon


OutcomesAdverse effects:
UTI: A, 1/80; B, 2/78
Buttock pain: A, 12/80; B, 0/78
Acute urinary retention: A, 0/80; B, 1/78
Dyspareunia after surgery: A, 4/80; B, 4/78
Vaginal dryness after surgery: A, 4/80; B, 4/78
Time to resumption of intercourse (mean weeks, range): A, 8 (4-16 weeks); B, 8 (5-16)
Sexual functioning: no differences between the groups after surgery (P>0.05)


NotesNo prolapse or incontinence outcomes reported (study was aimed at evaluation of sexual functioning).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear riskB - Unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskunclear

Other biasUnclear riskCOI and funding not stated

Kahn 1999

MethodsSingle centre RCT (number table randomisation, concealment unclear)
Follow up: 25 months (8-37) A+B


Participants63 randomised
Withdrawal: 4 (A 2, B 2)
Excluded: 2 (one no rectocele surgery because posterior vaginal wall cyst, one did not get the surgery performed)
Inclusion: symptomatic rectocele or sense of impaired rectal emptying with >15% trapping on isotope defecography


InterventionsA (24): posterior colporrhaphy with levator plication, enterocele repair, hysterectomy, anterior repair as required
B (33): transanal repair by single colorectal surgeon, circular muscle plicated longitudinally, permanent suture


OutcomesObjective cure of recto/enterocele: A: 21/24, B: 23/33
Change in POP-Q (Ap or Bp) score: A: 1 stage, B: 0
Improved or cured obstructed defecation A: 12/20, B: 14/24
Need for vaginal digitation


NotesNo blinding
No stratification
No CONSORT
Who reviewed outcomes unclear
No validated symptom or QoL questionnaires.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risknumber table randomisation

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskCOI not stated

Lo 1998

MethodsSingle centre RCT (using random number tables)
Follow up: 1 to 5.2 years (median 2.1)


Participants138 randomised, 20 withdrew due to age or not willing to be followed up
Inclusion: prolapse at least Grade III (ICS classification)
Exclusion: urinary incontinence
Past medical history: previous pelvic surgery A: 19, B: 22
Sexually active: A: 11, B: 18


InterventionsA (52): abdominal sacral colpopexy with Mersiline mesh: + 7 posterior repair; + 12 posterior repair and abdominal hysterectomy; + 21 abdominal hysterectomy
B (66): vaginal sacrospinous colpopexy with 1-0 nylon: + 20 anterior and posterior repair and vaginal hysterectomy; + 44 anterior and posterior repair
Post-operatively, all women had oestrogen treatment


OutcomesSuccess defined as ICS grade II or less
Objective success rate (all prolapse): A: 49/52, B: 53/66
Operation time (min): A: 157 (SD 35), B: 141 (37)
Blood loss (ml): A: 150 (137), B: 448 (258)
Hospital stay (days): A: 7.24 (2.07), B: 8.77 (3.8)
Prolonged catheter use: A: 0/52, B: 17/66
Post-operative UTI: A: 2/52, B: 4/66
Dyspareunia: A: 1/11, B: 11/18 (4 of the 11 severe)
New urinary incontinence requiring later operation: A: 2/52, B: 1/66
Adverse effects requiring re-operation: A: 4/52, B: 7/66
Adverse effects A: 2 continence operations, 1 retroperitoneal infection and mesh removal, 1 ureteral injury
Adverse effects B: 1 continence operation, 1 rectovaginal fistula, 2 vaginal vault strictures, 3 perineal infections


NotesGroups stated to be comparable at baseline on age, parity, weight and previous pelvic surgery
No blinding
No CONSORT
Who reviewed outcomes unclear
No validated symptom or QoL questionnaires.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskrandom number list

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskno COI or funding statement

Maher 2004

MethodsRCT (stratified by SUI)
Multi-centre, multi-surgeon
Computer generated randomisation held by non-surgical co-author
Follow up: A: 24 months, B: 22


Participants95 women
Withdrawals: 0
Lost to follow up: 6 (A: 1, B: 5)
Inclusion: vault prolapse to introitus
Exclusion: prior sacral colpopexy, unfit for general anaesthetic, foreshortened vagina


InterventionsA (46): abdominal group = sacral colpopexy prolene mesh, paravaginal repair, Moschcowitz, posterior vaginal repair and colposuspension for SUI
B (43): vaginal group: R sided sacrospinous colpopexy, enterocele and anterior and post repair, colposuspension for SUI,
PDS (slowly absorbable sutures)

Both groups: colposuspension for occult or potential SUI


OutcomesSubjective cure (no prolapse symptoms): A: 43/46, B: 39/43
Objective cure (site specific stage 2 or greater failure at any site) : A: 35/46: B: 29/42
Satisfied with surgery: A: 39/46, B: 35/43
Number of women sexually active: A: 19/42, B: 17/37
Dyspareunia: A: 6/19, B: 7/17
Dyspareunia (de novo): A: 2/19, B: 3/17
Preoperative SUI cured: A: 11/14, B: 13/15
De novo SUI postoperatively: A: 2/22, B: 8/24
Preoperative voiding dysfunction cured A 7/9: B 4/5
Peri-operative outcomes:
Blood loss (ml): A: n=47, mean=362 (SD 239), B: 48, 306 (201)
Operating time (minutes): A: 47, 106 (37), B: 48, 76 (42)
Postoperative complications: A: 1 mesh infection requiring removal, 2 incisional hernia, B: 0
Further prolapse surgery:
Further prolapse or continence surgery: A: 4/46, B: 5/43
Cost: (US dollars) A: 4515: B: 3202
Hospital stay (days): A: 47, 5.4 (2.2), B: 48, 4.8 (1.4)
Time to return to normal activity: A: 47, 34 (12), B: 48, 25.7 (9.7)


NotesNo blinding
Intention to treat
Non surgeon follow up
No CONSORT
Validated symptom and QoL questionnaires.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskrandom number list

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot possible

Blinding of outcome assessment (detection bias)
All outcomes
High risknon-blinded reviewers, participant-completed validated questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskadequately accounted for

Other biasLow riskfunded by competitive research grant RANZCOG:

Maher 2011

Methodssingle centre RCT

appropriate randomisation, stratified urinary stress incontinence

allocation concealment

blinded non surgeon reviewer

allocation concealment

intention to treat analysis

consort compliant

80% power to detect 30% difference between the groups with 5% type error with 47 in each group


ParticipantsInclusion criteria were consecutive women with symptomatic stage 2 or greater (point C ≥ -1 POP-Q) vault prolapse

Excluded with

Age < 18, inability to comprehend questionnaires,

to give informed consent or to return for review, vault prolapse < St. 2, unable to undergo general anesthesia, BMI > 35,  ≥5 previous laparotomies, prior sacral colpopexy,

or vaginal mesh prolapse procedure, vaginal length < 6cm

suitable participate 142

randomised and surgery A 53 B 55

lost to full follow up 2 years

A 2 B 3


InterventionsGp A laparoscopic sacral colpopexy

Gp B TVM Prolift

concomitant surgery yes

SUI or occult sui

A lap colposuspension B TVT-O

posterior repair and paravaginal surgery if required in A


Outcomesobjective success (less than point -1cm any point POPq) A 41/53 B 23/55

subjective success (awareness prolapse) A52/53

B 51/55

A B

Aa -2.09 +- 0.56 -1.44  +-1.24

Ba -2.17 +-0.51 -1.50  +- 1.19

C -7.48  +-2.62 -6.11  +- 2.72

TVL 8.83  +-.55 7.81  +-1.4

Ap -2.32  +-.61 -1.65  +-1.05

Bp -2.3  +-0.64 -1.63  +-1.05

Urodynamic findings A B

voiding dysfunction 5/53 4/55

OAB 20/53 14/55

USI 7/53 14/55

mesh exposure A 1 B 7

operation mesh exposure A 0 B 5

reoperation Prolapse A 0 B 3

reoperation related primary surgery A 3 B 12

mesh contraction surgery A O B 4

complications

A cystotomy 1 enterotomy 1: B hematoma infected

peri-operative results reported median and range

operating time A greater than B

and A reduced blood loss, inpatient time and time to return to activities of daily living

QOL Australian Pelvic floor questionnaire improved outcome in both groups

P-QoL questionnaire; again reduced in both groups and no difference between groups


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskcentral randomisation

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot possible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskblinded non-surgeon reviewers validated patient completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskflow patients accounted for

Other biasLow riskfunded by competitive research grant Australian Gynaecology Endoscopy Society authors no conflict of interest reported

Menefee 2011

Methodsdouble blinded triple arm RCT

randomisation, allocation concealment, NS power 33 in each group 80% power to detect 35% difference with 5% type 2 error

2 year review


Participantsinclusion:Women ≥ 18 years of age with a Pelvic Organ Prolapse Quantification (POP-Q) point Ba of ≥ 0

exclusion NS

concomitant surgery: hysterectomy, colpopexy, posterior repair, continence at surgeons discretion


Interventions99 randomised

A 32: standard anterior colporrhaphy using midline plication with delayed absorbable suture

B 31 vaginal paravaginal repair using free-hand formed porcine dermis graft (PelvicolTM)

C 36 vaginal paravaginal repair using free

formed polypropylene mesh (M). All graft material was secured to the arcus tendineus fascia pelvis using a Capio™ device with permanent mono-filament suture


Outcomessuceess rate definition stage 0 and 1 anterior compartment

A 10/19 B 12/23 C 25/29

symptomatic failure: A 3/19 B 3/23 C 1/29

reoperation A 0 B2 C 0

graft erosion: A0 B 1/23 C 4/29

QOL outcomes All three groups had a reduction in

their prolapse and urinary symptom severity and degree of bother without significant differences between groups


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated sequence

Allocation concealment (selection bias)Low riskopaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskdouble blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskdouble blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskall data accounted for

Other biasHigh riskauthors report COI with companies producing product evaluated and funded by Boston whose product capio was being evaluated

Meschia 2004

MethodsRCT (sealed envelopes with numbers assigned from a computer generated random number list)
Comparing TVT and plication of urethrovesical junction endopelvic fascia in addition to prolapse repair
Single centre (Milan, Italy)
Follow up (median): A: 26 months (range 15 to 31 months), B: 24 (15 to 31)


Participants50 women
Inclusion: severe symptomatic genital prolapse and occult stress urinary incontinence
Exclusion: age >70 years, BMI > 30, diabetes, previous pelvic or continence surgery, symptoms of SUI, detrusor overactivity, cotton-swab test > 30 degrees
Age: mean 65 years (SD 8)
Parity: 2.2 (0.8)
BMI: 25 (3)


InterventionsA (25): prolapse repair and TVT (with prolene tape)
B (25): prolapse repair and urethrovesical plication (with 2-0 permanent-braided polyester sutures)
All women also had vaginal hysterectomy, McCall culdoplasty and cystocele repair
Cystocele (anterior repair) with 2-0 delayed absorbable sutures (polydioxanone)
No sacrospinous ligament fixation performed
Rectocele repair: A: 20/25, B: 23/25


OutcomesSubjective prolapse symptoms, failure rate: A: 4/25, B: 8/25
Objective failure (overall): A: 8/25, B: 7/25
Objective failure (anterior): A: 6/25, B: 7/25
Objective failure (posterior): A: 3/25, B: 3/25
Objective failure (apex): A: 0/25, B: 3/25
Further prolapse surgery: offered to 2 women but groups not specified
Further continence surgery: A: 0/25, B: 3/25
SUI subjective: A: 1/25, B: 9/25
SUI objective: A: 2/25, B: 11/25
OAB de novo (new): A: 3/25, B: 1/25
Voiding dysfunction and recurrent UTIs: A: 3/25, B: 1/25
Adverse effects: A: 2 (bladder perforation, retropubic hematoma), B: 0
Peri-operative outcomes
Operation time (minutes): A: 131 (SD 13), B: 112 (21)
Blood loss (ml): 188 (77), B: 177 (102)
Hb change: A: 1.8 (1.6), B: 1 (1.2)
Days in hospital: A: 6.4 (1.5), B: 6.1 (1.5)
Time to spontaneous voiding (days): A: 4.4 (1.7), B: 3.8 (2)


NotesPower calculation provided
Groups comparable at baseline.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPC generated randomisation

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskall data accounted

Other biasUnclear riskno statement

Meschia 2004a

MethodsRCT (computer generated number table, opaque envelopes) on posterior IVS and sacrospinous fixation for vault prolapse
Median follow up: A 19, B 17 months


Participants66 randomised
A 33, B 33
No withdrawals or losses to follow up
Inclusion: vault (vaginal cuff) prolapse ICS stage II or more
Baseline stress urinary incontinence: A 11/33, B 7/33
Baseline overactive bladder: A 14/33, B 11/33
Baseline voiding dysfunction: A 19/33, B 18/33
Women in Group A were significantly younger than in group B (63 years vs 68 yrs, P<0.05)


InterventionsA (33): infracoccygeal sacropexy (posterior IVS) using multifilament Polypropylene tape
B (33): sacrospinous ligament fixation (vaginal sacrospinous colpopexy)
Concomitant surgery: anterior (A 64% B 66%) and posterior (70%, 88%) repair, high closure of pouch of Douglas if indicated (36%, 42%)


OutcomesPrimary outcome: recurrence of prolapse at any site (data not provided)
Subjective prolapse sensation: A 3/33, B 2/33
VAS prolapse sensation (0-10) N, mean (SD): A 33, 2.4 (3.3), B 33, 1.8 (2.1)
Vault prolapse at ICS point C stage II: A 1/33, B 0/33
Anterior vaginal wall prolapse stage II or more: A 9/33, B 11/33
Posterior vaginal wall prolapse stage II or more: A 4/33, B 6/33
Operative time mean min, (SD): A 58 (17), B 69 (17)
Blood loss mean ml (SD): A 56 (35), B 126 (21)
Days in hospital mean (SD): A 3 (1.1), B 4 (1.7)
Complications: Pararectal abscess A: 1/33, B 0/33; Vaginal vault erosion: A 3/33, B 0/33; Buttock pain: A 0/33, B 4/33
Postoperative voiding dysfunction: A 6/33, B 8/33
Stress urinary incontinence: A 5/33, B 5/33
Overactive bladder: A 9/33, B 10/33
Dyspareunia: A 0/33, B 1/33
Constipation: A 3/33, B 2/33
Faecal incontinence: A 1/33, B 1/33


NotesAbstract and further data from authors
No stratification
No CONSORT statement
No intention to treat
No power analysis
No validated QoL or pelvic floor questionnaires.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPC generated randomisation

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata complete

Other biasUnclear riskno statement

Meschia 2007

MethodsMulticentre RCT (computer generated) on primary surgery anterior vaginal wall prolapse
Allocation concealed

Power calculation: 90 in each arm required

Follow up: 2 years

Intention-to-treat analysis: yes, including those women with missing data at two years but with 1 year follow up completed


Participants206 randomised
Lost to follow up 5: A 2 B 3
Inclusion: primary anterior prolapse POP-Q Point Ba -1 (>=stage II)
Exclusion: none
Baseline stress urinary incontinence: A 22/100, B 18/106
Baseline overactive bladder: A 44/100, B 35/106
Baseline sexually active: A 65/100, B 74/106; with dyspareunia: A 12/65, B 11/74

No differences between the two groups with respect to demographic and clinical characteristics

At two years number available for analysis:176 (A 91; B 85)

Intention-to-treat analysis: 201 analysed (A 103; B 98)


InterventionsA (100) interrupted fascial plication Vicryl 00 WITH Pelvicol overlay fixed with PDS suburethrally and uterosacral cardinal ligament distally
B (106): surgery as above WITHOUT Pelvicol overlay
Concomitant surgery standardised
Vaginal hysterectomy McCall culdoplasty, posterior compartment defect fascial plication


OutcomesObjective (POP-Q point Ba -1): A 7/98 (7%) B 20/103 P=0.0019, OR 3.13 CI 1.26-1.78
Subjective symptoms of prolapse: A 9/98 (9%) B 13/103 (13%)
VAS prolapse severity: (SD): A 1.5 (1.7), B 1.5 (1.6)
Adverse effects: haematoma: A 3/98, B 0/98
Length of stay, mean days (SD): A 4.4 (1.5), B 4.7 (1.3)
Blood loss ml (SD): A 151 (112), B 167 (96)
Time to voiding mean days (SD): A 3 (3.2), B 3.5 (3)
Voiding dysfunction: A 15/98 (15%), B 16/103 (15%)
Overactive bladder: A 15/98 (15%), B 18/103 (17%)
Stress urinary incontinence: A 10/98 (10%), B 14/103 (13%)
Sexually active: A 47, B 48
Dyspareunia: A 7/47 (15%), B 5/48 (10%)

At 2 years: primary outcome measure = rate of anterior vaginal prolapse recurrence

Anatomic outcomes were defined according to the ICS recommendations

Overall subjective failure (both groups): 20/176 (11%)

Objective failure (unsatisfactory anatomic outcome point Ba): A 9/85 (11%); B 20/91 (22%); P=0.07

Intention-to-treat analysis (including women with missing data at two years but with 1 year follow-up completed):

Objective failure (ITT): A 11/98 (11%); B 24/103 (23%); P=0.04

Graft rejection necessitating removal: A 1/98, B 0/103


NotesNumber of patients approached or declined unclear
No CONSORT

The authors concluded that the use of Pelvicol implant can improve anatomic outcomes in the anterior vaginal compartment.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Low riskA - dequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskno patient completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskno statement

Minassian 2010 abstract

Methodssingle centre 2 surgeon RCT

randomisation list PC generated and sealed opaque envelopes

32 in each group had 80% power to to detect 25% difference with 5% type 1 error

blinding and who reviewed NS


ParticipantsInclusion criteria were women over the age of 18 with symptomatic cystoceles scheduled for reconstructive surgery. Patients were excluded if they were pregnant or planning to have a future pregnancy, two previous failed anterior vaginal wall repairs


InterventionsA 34 AC , plication of the cystocele in the midline was performed with 0-polydioxanone interrupted mattress sutures over a polyglactin 910 (vicryl) mesh within the imbricated fold of vaginal muscularis and adventitia;

B 35 paravaginal defect repair, 0-polydioxanone sutures were used to attach the pubovesical fascia to that of the obturator and pubococcygeus muscle, also over a vicryl mesh

2 surgeons

concomitant POP and continence surgery allowed

majority undergoing sacral colpopexy


Outcomesobjective failure ≥stage II POP anterior wall A 12/34

B 10/35

subjective awareness of bulge: A 1/34 B 3/35


Notesthe impact of sacral colpopexy on point Ba would be significant and we await full publication

only 1/3 of patients currently at 2 years


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata incomplete

Other biasUnclear riskno statement

Natale 2009

MethodsCONSORT statement: No

Power calculation: 100 in each arm

Type of randomisation: computer generated

Blinding strategy: not specified

Allocation concealment: not specified

Definition of cure: point Ba<−1 (i.e. stage 0 or 1 according to the POP-Q system)

Follow up: 24 months

Prolapse assessment: POP-Q

update of Cervigni 2005 abstract


ParticipantsInclusion: recurrent, symptomatic stage 2 or greater anterior vaginal wall prolapse (point Ba >/= -1) planning to undergo secondary pelvic reconstructive surgery

Exclusion: patients needing a concomitant anti-incontinence procedure and patients with diabetes mellitus or collagen disease

Randomised: 190

Analysed: 190

Women were comparable at baseline on demographic data, degree of POP, and clinical or urodynamic findings. Previous hysterectomy: A 60/96, B 54/94


InterventionsA (96): cystocele repair with armed monofilament polypropylene mesh (Gynemesh)

B (94): cystocele repair with armed porcine dermis graft (Pelvicol)

Concomitant surgery: not specified. Prophylactic antibiotic cover.

All underwent tension-free cystocele repair (TCR) and levator myorrhaphy and vaginal hysterectomy if required.

The sheets of both the Pelvicol graft and the synthetic mesh were trimmed to an identical rounded shape, with two lateral wings/arms. In each operation, the central, rounded part of the graft was positioned under the urinary bladder in a tension-free fashion, while its arms were inserted deep into the periurethral tissue on both sides towards the pubic bone. A single fixating monocryl 2/0 suture was performed at the base of one wing of the mesh, at the periurethral level.


OutcomesObjective failure: A 27/96; B 41/94; P=0.06

Stress Urinary Incontinence de novo: A 2/96; B 1/94

Increased daytime urinary frequency: A pre 33, post 26/96; B pre 42, post 6/94

Dyspareunia: A pre 20, post 10; B pre 29, post 12; not significant

PISQ-12: A: No change between pre-op and post-op scores P=0.31; B: Significant improvement between pre-op and post-op scores p=0.03.

P-QoL (post-op scores): B superior to A in social limitations P=0.04 and emotions P=0.02

In both groups significant and equal reduction in slow urinary stream and incomplete bladder emptying following intervention

In both groups non-significant but equal reduction in urinary urgency, urge incontinence and nocturia

Mesh erosion over-sewing: A 6/96; B 0/94

3 Year outcomes

Objective failure rate (Aa or Ba A)


NotesThe trialists concluded that Gynemesh was not statistically significantly superior to porcine graft in the management of anterior compartment prolapse at 2 years. Sexuality and P-QOL was superior in the porcine graft group as compared to the Gynemesh PS.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskunclear

Other biasUnclear riskno statement

Natale 2010

MethodsSingle centre multiple surgeon RCT on vaginal vault suspension at time of vaginal hysterectomy

No CONSORT statement, and allocation concealment not mentioned,

PC generated randomisation list

Power calculation: 80% power, 110 patients in each study arm to detect a 15% reduction in vaginal vault prolapse. In order to allow for a 10% dropout rate, sought to enrol 120 subjects in each study arm.

POPQ, urodynamics, Q-tip test

PQoL, Wexner score for constipation and PISQ-12


Participants229 women with apical POP stage 2 or more

excluded sui, prior hysterectomy or prolapse or continence surgery

All completed one-year follow up

Demographic parameters and previous prolapse surgeries did not differ between the two groups.


InterventionsA: n= 116 high levator myorrhaphy

B: n= 113 uterosacral vault suspension

Concomitant surgery in all women: vaginal hysterectomy and "tension-free" cystocele repair with self-styled monofilament polypropylene mesh Gp A113 and Gp B 106. Operations performed by three different surgeons


OutcomesDemographic, urodynamic and prolapse data at baseline similar in groups

Apical stage 2 recurrent prolapse in A 6/116 (5%) and B 5/113 (4%);

Anterior stage 2 prolapse in A 34/116 (29%) and B 40/113 (35%);

Posterior stage 2 prolapse in A 12/116 (10%) and B 11/113 (10%)

Mean post-operative total vaginal length in A 7.9 cm and B 9.1 cm; p=0.03.

No difference in first desire to void, bladder capacity, pressure at maximum flow, maximum flow. Detrusor overactivity present in A 17/116 (25%) and B 55/113 (49%)

De novo symptoms in abstract only (different patient numbers):

stress urinary incontinence in A 5 (9%), B 8 (14%)

urge incontinence in A 0 and B 7 (12%)

urgency in A 2 (3%) and B 5 (9%)

Increased daytime frequency in A 3 (5%) and B 9 (16%)

nocturia in A 6 (10%) and B 7 (12%)

slow stream in A 11 (19%) and B 5 (9%)

de novo dyspareunia in Gp A 7 (6.1%) and Gp B 9 (7.6%) groups

constipation in A 7 (12%) and B 8 (14%).

Complications:

angulation of ureter with hydronephrosis in 10 patients (8%) in group B

mesh erosion in A 12 (10%) and B 16 (14%);

significant improvement in PQOL scores in both groups

No differences in symptoms, PISQ-12-scores, Wexner score for constipation, urodynamic data or prolapse degrees between groups


NotesNatale et al (ICS 2007, abstract) assessed two procedures for suspension of the vaginal vault: High Levator Myorrhaphy (HLM; 58) and Uterosacral Vaginal Vault Suspension (UVVS; 58) in patients with stage 2 prolapse. All women underwent anterior repair with polypropylene mesh and vaginal hysterectomy concomitantly. Demographic parameters and previous prolapse surgeries did not differ between the two groups.

At follow up, apical compartment recurrence rate was lower although not significantly in the LM group as compared to the UVVS group (2/58 versus 15/58) but the mean total vaginal length (TVL) was significantly smaller (7.2 versus 8.9 cm). Post-operative detrusor overactivity was less prevalent among patients in the LM arm (17/58 versus 22/58, P=0.05) although figures for bladder function pre-operatively are not given. Post-operative unilateral ureteric angulation leading to hydronephrosis was identified in 5/58 patients in the UVVS group and required a further surgical intervention for removal of a suture. Mesh erosion rates were comparable between the two groups. Weaknesses of this study include the lack of exclusion criteria, length of follow up, peri-operative data and a clear definition for success or failure.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata complete

Other biasUnclear riskno COI statement

Nguyen 2008

MethodsSingle centre RCT on anterior vaginal prolapse

CONSORT statement: yes

Power calculation: 38 in each arm

Type of randomisation: computer generated

Blinding strategy: primary surgeon - till the surgery day; patients, research nurse and medical assistant remained blinded

Allocation concealment: sealed opaque envelopes

Definition of cure:

Ant wall POP-Q St. < 2, ‘Optimal support’ = Aa and Ba at St. 0, ‘Satisfactory’ = Aa and Ba at St.1 and improved from pre-op staging

Follow up: 12 months (full publication) and 24 months (abstract only)

Prolapse assessment: POP-Q


ParticipantsInclusion: 21 years and older with POP-Q stage 2 or greater anterior prolapse requiring surgical correction

Exclusion: pregnancy (present or contemplated), prior repair with graft, systemic infection, compromised immune system, uncontrolled diabetes mellitus, previous pelvic irradiation/cancer, polypropylene allergy, scheduled for concomitant Burch or pubovaginal sling

Randomised: 76

Withdrawals: 1

Lost to follow up: 1

Analysed: 76


InterventionsA (38): anterior colporrhaphy (AC) with delayed absorbable (PDS) sutures

B (38): AC + polypropylene four armed mesh kit repair (Perigee, American Medical Systems)

Concomitant surgery: vaginal hysterectomy, bilateral salpingo-oophorectomy, uterosacral suspension, mid-urethral tape, site-specific rectocele repair, perineoplasty, Apogee mesh kit repair.

Concomitant prolapse and suburethral tape surgeries were performed in both groups


OutcomesDefinition of failure: POP-Q stage 2 anterior prolapse.

Objective failure: A 20/38 (53%); B 5/38 (14%); p=0.01

Hb change at day 1 post-op (median): A 1.8 (g/dl); Gp B 2.4 (g/dl); p=0.02

Blood transfusion: A1/38, B 1/38

Further prolapse surgery: A 1/38; B 0/38

Further continence surgery: A 1/38; B 0/38

Validated questionnaires:

A pre PFDI-20 109±58; post PFDI-20 45±32

B pre PFDI-20 108±45; post PFDI-20 34±31

A pre PFIQ-7   45±32;   post PFIQ-20 23±34

B pre PFIQ-7   82±54;   post PFIQ-20 14±23  

In both groups the change in PFDI and PFIQ scores after surgery is highly significant P=0.001

Mesh erosion: A 0, B 2/38

Definition of dyspareunia: ‘usually’ or ‘always’ to item 5 at the PISQ-12

Dyspareunia de novo: A 4/26 (15.4%), B 2/22 (9.1%)


NotesData regarding study methodology was obtained from the full published article, follow up at 12 months

PFDI - pelvic floor distress quality of life measure

PFIQ - pelvic floor incontinence questionnaire (quality of life measure).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskparticipants blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskassessors blinded; participant-completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata set complete

Other biasUnclear risknot statement

Nieminen 2004

MethodsSingle centre RCT (nurse took card from envelope with 15 vaginal and 15 transanal cards)
Follow up: A 12 months, B 12 months


Participants30 women
Inclusion: symptomatic rectocele
Exclusion: any other prolapse or compromised anal sphincter function
42 eligible women participated
12 excluded due to compromised anal sphincter function
30 analysed
No loss to follow up


InterventionsA (15): midline rectovaginal fascia plication Vicryl repair
B (15): transanal repair performed by 2 colorectal surgeons
Vertical and horizontal Vicryl sutures, enterocele repaired


OutcomesImprovement symptoms A: 14/15: B 11/15 (P=0.08)
Postoperative mean reduction Ap A 2.7: B 1.3 (P=0.01)
Depth rectocele defecography
Recurrent posterior wall prolapse (rectocele or enterocele): A 1/15, B 10/15 (P=0.01)
Continuing need to digitally assist rectal emptying postoperatively A: 1/11, B 4/10
Sexually active: A 12/15, B 11/15
Dyspareunia: A 4/12, B 2/11
Incontinence to flatus: A 4/15, B 3/15
Incontinence to faeces: A 0/15, B 0/15
Peri-operative outcomes:
Operating time: A 35 minutes: B 35 minutes
Blood loss ml: A 120, B 60
Discharged from hospital in 48 hours: A 13/15: B 11/15.


NotesFull text
No intention to treat
No CONSORT.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskno statement

Nieminen 2008

MethodsMuti-centre RCT on anterior vaginal prolapse

CONSORT statement: yes

Power calculation: 101 in each arm

Type of randomisation: computer generated

Allocation concealment: opaque envelopes

Blinding strategy: not specified, but lack of a non-surgical blinded outcome reviewer

Definition of cure: less than stage 2 prolapse at Aa or Ba

Follow up: 24 months

Prolapse assessment: POP-Q


ParticipantsInclusion: post-menopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond

Exclusion: apical defect indicating vaginal fixation or stress urinary incontinence necessitating surgery or the main symptomatic prolapse component was in the posterior vaginal wall. Also patients with gynaecological tumour or malignancy calling for laparotomy or laparoscopy and those with untreated vaginal infection.

Randomised: 202

Withdrawals: 1

Lost to follow up: 1

Analysed: 200

No significant differences in baseline demographics, prior hysterectomy or prolapse surgeries between the two groups


InterventionsA (96): anterior colporrhaphy (AC) using a 0 or 2/0 multifilament suture

B (104): AC + self-tailored (from a 6 x11 cm mesh patch) 4 armed low-weight polypropylene mesh

Type of mesh: non-absorbable monofilament polypropylene (Parietene light, Sofradim, France)

Sutures for AC: absorbable 0 or 2/0 multifilament suture

Concomitant surgery: vaginal hysterectomy, posterior repair, culdoplasty as required, no concomitant continence surgeries were performed


OutcomesObjective failure: A 39/96; B 12/104

Symptomatic prolapse: A 35/96; B 27/104; P=0.11

Awareness of bulge at 1 year: A 6/93, B 7/107

Awareness of bulge at 2 years: A 17/96; B 5/104; P=0.003

Further prolapse surgery: A 1/96; B 1/104

Further continence surgery: A 6/96; B 5/104

Operating time mean (min): A 58+/-26; B 73+/-26; P<0.001

Blood loss mean (ml): A 114+/-109; B 190+/-23; P=0.004

Stress incontinence de novo: A 9/96; B 15/104

Mesh erosion: A 0, B 8/104 (at 1 year follow up erosion rate was reported as 18/104)

3 year outcomes

objective failure rate (Aa or Ba ≥ -1) A 40/97 B 14/105

awareness bulge A 18/96 B 10/104

reoperation prolapse A 10 ( 9 anterior compartment 1 anterior & posterior) B 6( o anterior compartment 6 posterior or apical)

continence surgery A 9 B 5

mesh exposures Ao B 20

reoperation mesh exposure B 14

adverse sexual function A 9 B 7

de novo stress urinary incontinence A 5/96 B7/104


NotesNieminen and colleagues compared anterior colporrhaphy alone and anterior colporrhaphy plus a self styled mono-filament mesh (Parietene light, Sofradim, France) in post-menopausal women with symptomatic anterior compartment prolapse at the hymen or beyond. Women were excluded if they had an apical defect indicating concomitant vaginal fixation or stress urinary incontinence necessitating surgery or the main symptomatic prolapse component was in the posterior vaginal wall. Also patients with gynaecologic tumor or malignancy calling for laparotomy or laparoscopy and those with untreated vaginal infection were excluded.

Concomitant surgeries including a vaginal hysterectomy and posterior repair were performed as required. No concomitant continence surgeries were performed.

In the mesh group a four armed graft was tailored from a 6 x11 cm mesh patch.

The anterior colporrhaphy was performed using a 0 or 2/0 multi-filament suture.

There were no significant differences in baseline demographics, prior hysterectomy or prolapse surgeries between the two groups.

At two years, the objective failure rates were significantly higher in those undergoing the anterior colporrhaphy alone (39/96) as compared to the anterior colporrhaphy with the self styled Sofradim Paritene polypropylene mesh (12/104). As pointed out by the authors, there was no difference in subjective awareness of prolapse between the two interventions (AC 35/96; mesh 27/104; P=0.11) although the operating time and blood loss were significantly greater in the AC + mesh group and eighteen patients (17%) in this group developed mesh erosion at one year and at two years the authors interestingly reported eight percent mesh exposures. At one and two years respectively, the number of women aware of bulge in the AC group was 6/93, 17/96 as compared to 7/107, 5/104 in the mesh group, which is highly significant (P=0.003). De novo stress urinary incontinence occurred in nine (9/96, 9%) from the AC group of which six underwent TVT and in 15 (15/104, 14%) from the AC + mesh group of which four underwent TVT. One subsequent prolapse surgery was required in each group (Cystocele in AC group and apical repair in the AC + mesh group). The weaknesses of the study included the lack of a non-surgical blinded reviewer

There were two inconsistencies between the one year and two year data. The reduction in mesh exposures from 17% at one year to 8% at two years is difficult to explain. Furthermore, the percentage of patients having undergone previous prolapse surgery at one year was 27% in the AC group and 18% in the mesh group while the two year report quotes 20% and 14% respectively.

There is also a further discrepancy. At one year the denovo SUI was A 9/96 as compared to 15/104 and at three years the reported rate is lower at 5/96, versus 7/104 rate. Even if some of these underwent continence surgery they should still be recorded as having de novo stress urinary incontinence.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated randomisation

Allocation concealment (selection bias)Low risksealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskdata complete

Other biasUnclear risknot clear

Pantazis 2011

MethodsRCT pilot comparing abdominal open and laparoscopic sacral colpopexy

CONSORT statement: No

Power calculation: commenced as pilot and completed 80% power to detect 1cm change in point C a sample size of 25 in each group was required

Type of randomisation: blocked computer generated. Patients randomised by procedure not by the surgeon with blocking to ensure that surgeons performed equal numbers of procedures.

Blinding strategy: Not specified

Allocation concealment: No

Definition of cure/failure: Not specified. Primary outcome is the level of the vaginal apex (change of point C)

Follow up: 12 weeks

Prolapse assessment: POP-Q


ParticipantsInclusion: symptomatic vault prolapse stage ≥ 2 POP

Exclusion: medical unfitness for a sacral colpopexy, and the need for any concomitant pelvic or continence surgery, BM!>35, prior prolapse surgery

Randomised: 30

Analysed: 30

Demographic characteristics were similar in both groups


InterventionsA (24): abdominal (open) sacral colpopexy

B (23): laparoscopic sacral colpopexy

No concomitant surgeries in either group


OutcomesMedian length of admission A 4.1 (1.6) days, B 3.2 (1.1) (P=0.07)

Point C mean in cm (SD): A -6.6 (1.4); B -6.7 (1.2) (P=0.71)

patients very much better Patient Global Impression - Improvment) Gp a 16/24 Gp B 13/23

PQol, PGI-I and Point C similar both groups 12 months

Hb drop day 2 post-op mean (g/dl): A 2.45 (n=15); B 1.35 (n=15); P=0.01, 95% CI 0.304 to 1.882

A 27 B 26

Operating time (mean min, SD, N): A 131 (44) 27, B 143 (28) 26

Estimated blood loss (mean ml, SD, N): A 240 (231) 27; B 56 (34) 26

reoperation prolapse Gp A 2/24 Gp B 2/23


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated blocked to ensure similar number patients per surgeon

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
High risknot blinded

Blinding of outcome assessment (detection bias)
All outcomes
High risknot blinded 1 year

Incomplete outcome data (attrition bias)
All outcomes
Low riskfull data set described

Other biasUnclear riskcompetitive grant Plymouth surgical services trust; COI for some authors in products being evaluated

Paraiso 2006

MethodsSingle centre RCT (computer generated randomisation by sealed envelopes with blinded research nurse)
106 randomised to posterior colporrhaphy (37), site-specific repair (37), site specific repair augmented with porcine small intestine submucosa (32: Fortagen, Organogenesis)
study funded unrestricted research grant Organogenesis


Participants106 women
Inclusion: grade II or greater posterior vaginal wall prolapse with or without other prolapse or incontinence or gynaecological procedures
Exclusion: concomitant colorectal procedures, allergy to pork


InterventionsA (37): posterior colporrhaphy as per Maher 2-0 Ethibond
B (37): site-specific repair Cundiff 2-0 Ethibond
C (32): as in B with 4x8 cm porcine small intestine submucosa graft inlay (Fortagen)


OutcomesObjective failure (Bp greater or equal to -2 at 1 year): A: 4/28, B: 6/27, C: 12/26
Subjective (functional) failure (worsening prolapse or colorectal symptoms at 1 year): A: 5/31, B: 4/29, C: 6/28
Operating time mean mins (SD): A: 150 (68), B: 151 (69), C: 169 (62)
Estimated blood loss mean (range): A: 150 (50-950), B: 150 (50- 600), C: 200 (50-3500)
Length hospital stay median days (range): A: 2 (1-19), B: 2 (1-6), C: 2 (1-6)
Intraoperative complications: A: 1/37 (3%), B: 2/37 (5%), C: 2/31 (6%)
Postoperative complications: A: 21/37, B: 14/37, C: 16/31
Reoperation for prolapse at 1 year: A: 1/33, B: 2/37, C: 3/29
Dyspareunia: A: 9/20, B: 6/22, C: 3/19
No differences between groups in condition-related quality of life outcomes (PFDI-20, PFIQ-7, PISQ-12)


NotesOngoing study: initial full text review after 1 year
Intention-to-treat basis
Consort statement
Independent nurse review
Limited sample size.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Low riskblinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded non surgeon reviewer

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskdata complete

Other biasUnclear riskunrestricted research grant from Organogenesis whose product was being evaluated

Paraiso 2011

Methodssingle centre single blinded RCT

randomisation stratified by surgeon: process computer generated list and and allocation concealment using opaque envelopes

reviewers blinded non-surgeons

participants blinded

primary outcome operating time from skin to closure

sample size 90% power to detect 30 minute difference in operating time with 5% type 1 error

cost to the healthcare system in 2011 US$ reported

1 year reviews with validated questionnaires Pelvic Floor distress inventory-20, Pelvic floor Impact questionnaire-7, Prolapse Incontinence sexual questionnaire

total operating time: skin incision to skin closure

concomitant surgery performed at surgeons discretion


Participantsinclusion: >21 years, Stages 2-4 apical post hysterectomy vaginal prolapse

Subjects were excluded if they were not candidates for general anesthesia, underwent a prior sacral colpopexy or rectopexy, had a suspicious adnexal mass or other factors that may indicate pelvic malignancy, reported a history of pelvic inflammatory disease, were morbidly obese (body mass index > 40 kg/m2), or were scheduled for a concomitant laparoscopic rectopexy with or without sigmoid resection.

concomitant continence and prolapse surgery at surgeons discretion


InterventionsA (32): laparoscopic SC

B (35): robotic assisted laparoscopic sacral colpopexy


OutcomesA 199 ± 46minutes

B 265 ± 50minutes

no difference length of stay or hospital pain medication, narcotic use or return to normal activities

A median non-steroidal anti-inflammatory use days 11

B 20

conversion to laparotomy or vaginal surgery

A 2 cystotomy,

B 3 2 cystotomy, enterotomy

cost A $14,324±2941 B $16,278±3326


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskadequate opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskpatients blinded 12 months

Blinding of outcome assessment (detection bias)
All outcomes
Low riskassessors blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskdata complete

Other biasLow riskfunded Cleveland clinic research institute and authors report no conflict of interest

Rondini 2011 abstract

MethodsRCT

randomisation, allocation concealment and blinding NS

power of 80% to detect 20% difference in cures rates between groups with 5% type 1 error


Participantsapical defects point C>3 inclusion

objective success point c <2

Demographics and PFDI-20, P-QOL, and PISQ-12 equal both groups pre-operatively

randomised A 63 B 61

declined surgery A 9 B 5


InterventionsA (54): sacral colpopexy

B (56): High uterosacral vault suspension


Outcomes12 months objective success (point C<stage 2): A 54/54; B 46/56

failure in anterior or posterior compartment (Ba or Bp≥ stage 3): A 3/54; B 19/56

reoperation for prolapse: A 3/54; B 10/56

operating time (min, SD): A 102 (27)) B 80(24)

hospital stay (days, SD): A 3.7 (0.5); B 2.1 (0.7)

intra-operative complications: A 3.7%; B 0% p=0.15)

post-operative complications: A 11/54; B4/56 (p=0.047)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated

Other biasUnclear riskno statement

Roovers 2004

MethodsRCT (computer generated random number table, allocation concealed) comparing abdominal and vaginal surgery for uterine prolapse

Follow up: A 12, B 12 months

Multi-centre RCT comparing abdominal and vaginal surgery for uterine prolapse

CONSORT statement: yes

Power calculation: 38 in each arm

Type of randomisation: computer generated random number table, allocation concealed

Blinding strategy: participating gynaecologists and study co-ordinator were kept blinded

Allocation concealment: sealed envelopes

Definition of cure/failure: failure defined as recurrent prolapse stage ≥ 2 plus symptoms of pelvic floor dysfunction

Follow up (mean): 94 months (range 84 - 120)

Prolapse assessment: POP-Q


Participants82 women
Inclusion: uterine prolapse stage 2-4 on POP-Q
Exclusion: uterus size > 12 weeks gestation, prior hysterectomy, adnexal mass, previous abdominal pelvic surgeries > 2, body mass index >35, prior inflammatory bowel or pelvic disease, faecal incontinence d/t sphincter defect

Offered participation: 124, 3 excluded, 39 refused to participate, 2 withdrew from abdominal group as wanted vaginal surgery

Randomised: 82 (41 in each arm)

Analysed: 82

At 8 years follow up: 74 of the original 84 patients were alive and able to be contacted. 60/74 (81%) completed questionnaires and 31/74 (42%) were examined.


InterventionsA (41): abdominal: sacral colpopexy with preservation of uterus: colposuspension for SUI
B (41): vaginal: vaginal hysterectomy with vaginal repair and uterosacral ligament plication: bladder neck needle suspension for SUI

Concomitant surgery: anterior colporrhaphy, posterior colporrhaphy, Burch colposuspension, Pereyra or Raz needle bladder neck suspension


OutcomesReoperation performed or planned: A 9/41, B 1/41
Urogenital distress inventory: no significant mean differences between A and B in domain score for genital prolapse (mean difference 4.1, 95% CI -5.4 to 13.6)
Scores on the UDI for: discomfort/pain domain (mean difference 7.1, 95% CI 1.1 to 13.2); overactive bladder domain (mean difference 8.7, 95% CI 0.5 to 16.9); or obstructed micturition domain (mean difference 10.3, 95% CI 0.6 to 20.1) were significantly higher in A than in B
Peri-operative outcomes:
operating time: A 97 (SD 3.6) min, B 107 (SD 4.7) min
blood loss: A 244 (51.5) ml, B 248 (34.1) ml
days in hospital: A 7.7 (0.2) B 7.6 (0.3)

Eight year follow up:

74/84 participants alive and contacted, 60 (71%) completed questionnaires, 31 (37%) were examined. No data provided about numbers in each randomised group at follow up therefore denominator is from original randomisation (and has increased to 42 in each group).

Women visiting a physician after surgery for pelvic floor symptoms: A 18/42 43%); B 8/42 (19%) P=0.03

Women reporting on improvement in prolapse symptoms post-op: A 29/42 (68%); B 37/42 (87%) P=0.09

Re-operation rate: A 11/42 (26%); B 6/42 (14%) P=0.28

IIQ scores and POP-Q scores were similar for both groups
Defecation symptoms had more adverse effect on quality of life in A than B. The difference in the constipation obstruction domain of the DDI was statistically significant.


NotesRCT compared vaginal hysterectomy in vaginal group with uterine preservation in abdominal group
No blinding
No stratification
Intention to treat
According to CONSORT
Non surgeon review
Validated questionnaire: UDI+IIQ
No sexual and bowel function outcomes

The authors concluded that long-term results of this RCT were consistent with short term results and demonstrated that vaginal hysterectomy with anterior and/or posterior colporrhaphy is preferable to abdominal sacral colpopexy with preservation of the uterus, as surgical correction of uterine prolapse.

We do not agree with these conclusions as there were no statistically significant differences in subjective or anatomical outcomes, reoperation rates or IIQ scores demonstrated. The statistically significant greater number of women visiting a physician with pelvic floor symptoms and  recording an adverse  effect on quality of life of the constipation/obstruction domain of DDI in the abdominal group as compared to the vaginal group would not be sufficient to support the authors' conclusion.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskrandom number chart

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
High riskunblinded

Blinding of outcome assessment (detection bias)
All outcomes
Low risknon-surgeon review

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskincomplete data set

Other biasUnclear riskno statement

Sand 2001

MethodsSingle centre RCT (computer generated number table)
Vaginal repair with or without Vicryl mesh overlay for cystocele and rectocele
Follow up: A 12, B 12 months


Participants143 women
Inclusion: cystocele to or beyond hymenal ring on standing
Exclusion: less than 18 years of age, pregnancy, contemplating pregnancy within one year, paravaginal defect only, anterior enterocele
161 randomised
1 excluded (anterior enterocele)
17 lost to follow up


InterventionsA (70): no mesh: Vicryl plication of anterior endopelvic fascia
B (73): mesh: as above with Vicryl mesh folded underneath trigone and cuff and secured Vicryl to fascia: also added to posterior wall if posterior repair performed
Posterior repair performed: A: 67/70, B: 65/73


OutcomesCure: POP-Q less than grade 2
Objective cure of cystocele: A 40/70, B 55/73 (P=0.02)
Objective failure for rectocele: A 7/67, B 6/65
Mesh erosion: A, 0/70 (not applicable); B, 0/73


NotesNo subjective success
No urinary, bowel or sexual function data
No peri-operative data
No intention-to-treat analysis
No CONSORT
No blinding
Standardised concomitant surgery
Review by surgeon.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear riskB - unclear

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskdata complete

Other biasUnclear riskno coi statement

Schierlitz 2007

MethodsMulti-centre RCT

Randomisation concealment NS

Intention to treat NS

Blinding assessors NS

6 month review


Participantsinclusion: symptomatically continent women with urodynamically demonstrable stress incontinence with or without reduction of prolapse (POP-Q stage 3 or greater)

exclusion NS

69 eligible

52 randomised

No loss to follow up


InterventionsA (27) non-standardised prolapse surgery without TVT

B (25) non-standardised prolapse surgery with TVT

No women had bladder neck plications


Outcomesprimary outcome repeat continence surgery A 1/27 B 0/25

Urodynamic stress incontinence A 9/27 B 1/25

Median subjective VAS < 80 (0-100) failure A 95; B 80 P=0.81 no range SD so unable to calculate

UDI, IIQ, PISQ questionnaires stated no difference no figures

I hour pad test stated no difference in figures


NotesOccult SUI was defined as symptomatically continent women with urodynamically demonstrable stress incontinence with or without reduction of the prolapse (POP-Q Stage 3 or greater).

The authors calculated a clinician would have to insert 26 TVT slings unnecessarily to prevent one woman needing a sling post-operatively and concluded routine insertion of a suburethral sling where occult stress urinary incontinence has been demonstrated prior to prolapse repair can not be recommended.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskunclear

Other biasUnclear riskno statement

Sivaslioglu 2008

MethodsSingle centre RCT comparing polypropylene mesh surgery with site-specific surgery in the treatment of cystocoele

CONSORT statement: Yes

Power calculation: 45 in each arm

Type of randomisation: computer generated

Blinding strategy: No (assessment was performed by non-blinded reviewers)

Allocation concealment: not specified

Definition of cure/failure: 'Acceptable cure' defined as cystocele less than -1 cm (stage 1 POP-Q)

Follow up: mean 12 months (range 8-16)

Prolapse assessment: POP-Q


ParticipantsInclusion: primary cystocele

Exclusion: stress urinary incontinence, concomitant rectocele or enterocoele or recurrent cystocoele

Randomised: 90 (45 to each arm)

Analysed: 85

Lost to follow up: 5


InterventionsA (42): site-specific Polyglactin 910 anterior repair

B (43): self-styled four armed polypropylene (Parietene, Sofradim, France) mesh, no anterior repair

Concomitant surgery not standardised, management of concomitant apical prolapse was not specified in either group


OutcomesObjective failure (stage 2 or more POP-Q): A 12/42; B 4/43; P<0.05

PQoL score post-op (mean±SD): A 7.5±6.2; B 6.2±5.5

No further prolapse surgery in either group

Stress urinary incontinence de novo: A 3/42; B 0/43

Dyspareunia de novo: A 0/42; B 2/43

Mesh erosion: A 0/42, B 3/43


NotesSivaslioglu and colleagues evaluated a site-specific Polyglactin 910 repair and self-styled four armed polypropylene (Parietene, Sofradim) mesh

The management of concomitant apical prolapse was not specified in either group and assessment was performed by non-blinded reviewers. Three patients in the AC group developed de-novo SUI and two in the mesh group developed de-novo dyspareunia. Operating time and blood loss are not described.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
High risknon-blinded reviewers objective assessment patient completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Low riskflow diagram: equal numbers and lost to follow up

Other biasLow riskno funding and no COI

Sung 2012

Methods2 centre double blinded randomised control trial:

allocation concealment sealed envelopes

randomisation block and stratified site

patients and assesssors blinded (patients unblinded 12 months)


ParticipantsInclusion criteria: women with stage 2 or greater symptomatic rectocele (defined as vaginal bulge, defecatory symptoms,
or both) electing surgical repair were eligible.
Exclusion criteria: <18years, women undergoing concomitant sacrocolpopexy, or colorectal procedures, history of porcine
allergy, connective tissue disease, pelvic malignancy,pelvic radiation, inability to understand English, or
unable or unwilling to consent or comply with follow up. All other vaginal prolapse repairs and anti-incontinence procedures were included.


InterventionsGp A 70 controls midline plication or site-specific repair

Gp B 67 midline plication or site-specific repair with 4x7cm subintestinal submucosal graft over the repair and secured to levator ani fascia using interrupted No. 2-0 polyglycolic acid and inferiorly to the perineal body using No. 2-0 polyglycolic acid sutures.

Excess vaginal tissue was trimmed in all women and the posterior vaginal incision was closed using 2-0 polyglycolic acid sutures The deep and superficial transverse perineal muscles and bulbocavernosus muscles were re-approximated using No. 0
polyglycolic acid sutures and concomitant perineorrhaphy was performed in all women.


Outcomes1 year review

objective failure Ap or Bp -1 or greater Gp A 6/70 Gp B SIS + repair 8/67 p=0.5

subjective failure: (defined as no improvement or worsening in bother or de novo symptoms)
for vaginal bulge or any of the three defecatory symptoms )straining or splinting with bowel movements, sensation incomplete evacuation

vaginal bulge Gp A 4/58 GP B 2/64

defecatory symptoms GP A 26/58 GP B 28/64

operating time and blood loss slightly greater Gp B reported as median and range

complications

Gp A 1 rectal injury: Gp B 1 cystotomy

vaginal stricture Gp A 1/70 Gp B 1/67

return to OT GP A 1 evacuate haematoma Gp B 1 oversow separated vaginal incision 2 weeks

Dyspareunia Gp A 4/57 Gp B 7/56 p=0.3


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated random sequence

Allocation concealment (selection bias)Low risksealed opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskblinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskblinded reviewers

Incomplete outcome data (attrition bias)
All outcomes
Low riskflow diagram complete

Other biasLow riskno financial conflict of interest and grant funding national institute of child and human health

Thijs 2010 abstract

MethodsMulti-centre and multi-national RCT

randomisation and allocation concealment NS

90% power to detect 20% difference urinary distress inventory prolapse domain at 1 year with 5% type 1 error with 38 in each group


ParticipantsA (48): anterior colporrhaphy

B (48): Perigee transobturator polypropylene mesh

A 35Ac only, 5 SSF, 5 hysterectomy, 6 midurethral sling

B 34 perigee only, 4 ssF, 8 hysterectomies, 1 mid-urethral sling


Interventionsinclusion stage 2 or more cystocele

excluded if anterior was not the leading prolapse

concomitant surgery allowed

stage 2 or more uterine prolapse hysterectomy or sacrospinous ligament fixation (SSF)

SUI mid-urethral sling


OutcomesA median 50 B median 100

blood loss >500mls A1 B 1

UDI: A versus B at baseline

discomfort: 27(24) 27(23)

overactive bladder: 34(30) 41(33)

obstructive micturition: 28(32) 19(20)

prolapse: 56(30) 58(35)

incontinence: 23(24) 19(20)

UDI:A vs B at 1 year

discomfort: 13 (19) 8 (12)

overactive bladder: 16(25) 15(23)

obstructive micturition: 15(23) 11(19)

prolapse : 12(22) 1(4)

incontinence: 18(29) 16(23)

B mesh erosion 9/48

B surgery mesh exposure 4/48


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot clear

Other biasUnclear riskno statement

Vijaya 2011 abstract

MethodsRCT with block randomisation

allocation concealment, power and consort NS

Pre and 6 months post-operatively anatomical outcome was assessed utilising the POP-Q and for the assessment of the subjective outcome the PQOL for quality of life, the FSFI for the sexual dysfunction and BBUSQ-22 for the bowel associated symptoms was utilised


Participantsinclusion: symptomatic posterior wall prolapse

exclusion: and concomitant surgery NS


InterventionsA (26): standard posterior colporrhaphy (with plication of the levator ani muscle)

B (26): fascial and vaginal plication repair.


OutcomesA mean difference pre and post-op -0.1.33(0.73) less than B mean difference: -2.01(0.73)

PQOL significantly different both groups post-operatively with no values given

no difference sexual function pre and post-intervention between the groups

Stated that Gp B significant improvement bowel evacuation post intervention although table compares pre-operative GP A with post-operative GP B


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risknot stated

Allocation concealment (selection bias)Unclear risknot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskunclear

Other biasUnclear risknot stated

Vollebregt 2011

Methodsmutli-centre RCT

Randomisation was computerised and stratification was performed for the presence of uterine descent ≥ 2. No blinding of group assignment was performed.

allocation concealment NS

power 80 to detect 25% difference in groups with 5%type 1 error from sample size of 50 in each group


Participantsinclusions:≥stage 2 cystocele

exclusion: history of urogynaecological surgery for pelvic organ prolapse or incontinence, cancer of COPD, concomitant urinary stress incontinence with an indication for surgical correction, recurrent lower urinary tract infections (> 3 culture proven infections/year), maximum bladder capacity < 300 ml, an indication for hysterectomy, and women with childbearing potential and inadequate birth control measures

randomised A 64 B 61

withdrawals prior to surgery A2 B2

12 months A 51 B 53


InterventionsA AC B trocar guided transobturator synthetic mesh AVULTA


Outcomesobjective failure rate ( ≥stage 2) A33/51 B 5/53

erosions B 2/53

reoperation erosion B 2/53

reoperation prolapse A2/51

de novo dyspareunia A 2/21 B 3/20

median (p25-p75) results no difference between groups UDI (Urogenital distress inventory) and IIQ Incontinence Impact questionnaire


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskresearch nurse from online list

Blinding of participants and personnel (performance bias)
All outcomes
High riskno

Blinding of outcome assessment (detection bias)
All outcomes
Low riskreviewers blinded by strapping thighs prior to review

Incomplete outcome data (attrition bias)
All outcomes
Low riskflow diagram accounts all patients

Other biasLow riskno funding and no COI

Weber 2001

MethodsRCT (computer generated random number tables. Sealed envelopes concealed assignment) comparing 3 surgical techniques
3 arms, 1 centre
Length of follow up: A+B+C, 23.3 months


Participants83 women
Inclusion: all women undergoing cystocele repair
Exclusion: continence surgery i.e. colposuspension or sling
114 randomised
5 withdrawals
26 lost to follow up (A 2:B 15: C 9) leaving 83 in trial


InterventionsA (33): anterior repair: midline plication without tension 0 PDS
B (24): ultralateral: dissection to pubic rami laterally, plication paravaginal with tension 0 PDS interrupted
C: (26) anterior repair plus mesh: standard plication midline Vicryl mesh overlay, Vicryl sutures


OutcomesObjective Aa and Ba less than or at 1 cm from introitus: A 10/33, B 11/24, C 11/26
Remaining data reported related to 83 women as a whole and did not differentiate between groups


NotesNumber and level of surgeons unknown
Adequate power
Non-standardised concomitant surgery
Intention to treat yes
No CONSORT
No stratification
Significant disparity in total numbers in Table 1 and actual numbers with prolapse reported
Except for point Aa POP-Q, no individual outcome data reported in the 3 groups.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)Low riskA - adequate

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risknot stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risknot stated

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNS

Other biasUnclear riskNS

Wei 2011

MethodsRCT Multi-centre single blinded, sham controlled at 7 clinical sites

Randomisation computer generated stratified by surgeon and type of prolapse

concealment NS

who conducted reviewers

80% power to detect 15% difference between the groups with 5% type 1 error

intention-to-treat analysis with missing data considered as treatment failures


Participantsvaginal prolapse surgery ( colpocleisis, apical suspension, anterior repair with Gp A sham procedure 172 Gp B Gynecare TVT 165

12 month review

inclusion criteria: vaginal prolapse surgery for symptomatic stage 2 anterior compartment prolapse and a negative response to 3 questions from PFDI relating to stress incontinence

exclusions prior sling placement, prior urethral surgery or radiation, planing pregnancy, 2 or more hospitalisations in the prior year,

at 3 months and 12 months patients reviewed and UI treated with medical or a variety of surgical options


InterventionsGP A vaginal prolapse surgery without TVT

Gp B vaginal prolapse surgery with TVT


Outcomesurinary incontinence defined at 3 months (stress, urge or mixed defined as +ve cough stress test, bothersome incontinence symptoms on 4 questions from the PFDI-3 relating to stress incontinence and 1 to urge incontinence or any treatment for incontinence)

12 month urinary incontinence stress, urge or mixed defined as +ve cough stress test, bothersome incontinence symptoms on 4 questions from the PFDI-3 relating to stress incontinence and 1 to urge incontinence

Positive cough stress test 12 months GP A 31/151 Gp B (with TVT) 5/143

Symptoms of incontinence Gp A 30/160 Gp B 18/158

subsequent continence surgery Gp A 8/160 Gp B 1/158

Subsequent surgery for voiding dysfunction Gp A 0/160 Gp B 4/158

Mean operative time was 11.4 mins longer and mean blood loss 24ml higher Gp B TVT as compared to Gp A prolapse surgery without TVT

Major bleeding Gp A 0/172 Gp B 5/164

Incomplete bladder emptying 6 weeks Gp A 0/170 Gp B 6/162

in those with preoperative occult stress incontinence ( positive prolapse reduction stress test) had urinary incontinence 12months Gp A 34/57 Gp B 19/54

in those with -ve pre-operative occult stress incontinence had urinary incontinence Gp A 46/113 Gp B 30/107

Pelvic Floor Urinary Impact Questionnaire (PFUIQ) Gp a -48.0 (65.9) Gp B -50.3 ( 71.3)


NotesOPUS trial: a significant weakness of the evaluation is that the definitions for inclusion as stress continent ( -ve answer to 3 PFDI questions relating to sui) were less stringent than the definition of UI positive as outcome includes +ve stress test, questions relating to stress or urge incontinence, or treatment for any incontinence. Actually as 108 ( Gp A 57 and Gp B 54) women had +ve prolapse reduction stress test prior to intervention they would have been deemed positive stress incontinence post-intervention and were -ve stress incontinence preoperatively on the criteria defined.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated block design stratified by surgeon and type of prolapse surgery

Allocation concealment (selection bias)Unclear riskallocation concealment not discussed

Blinding of participants and personnel (performance bias)
All outcomes
Low risksham dressings

Blinding of outcome assessment (detection bias)
All outcomes
Low riskoutcomes were questionnaires by blinded reviewers: cough stress test doesnt say who performed and were they blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskintention to treat and failure of review counted as failure

Other biasLow riskgrants from Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Health Office of research on Women Health

Withagen 2011

Methodsmult-centre randomised controlled trial

13 centres 22 surgeons

randomisation list computer generated for each 13 centres. allocation concealment not discussed and neither patient, surgeon or assessor (surgeons) were blinded

surgeons underwent specific Prolift mesh training

Full power calculation completed


Participantsrandomised GP A 99 Gp B 95

1 year examination A 84 B 83

inclusion criteria included recurrent stage II or higher anterior and or posterior wall prolapse and those with pregnancy, future pregnancy, prior vaginal mesh repair, a compromised immune system or any other condition that would compromise healing, previous pelvic irradiation or cancer, blood coagulation disorders, renal failure, upper urinary tract obstruction, renal failure and upper urinary tract obstruction, or presence of large ovarian cysts or myomas where excluded.


InterventionsGp A conventional surgery was performed at the discretion of the surgeon although absorbable sutures were specified and hysterectomies permitted.

Gp B standardised and structured in the Tension-free vaginal mesh: performed as described by Fatton (Fatton 2007) previously and no hysterectomies were performed or T incisions allowed


Outcomesdefinition success is unorthodox and different in methodology ( ≥ grade 2 prolapse in the treated site) and results section ( ≥ grade 2 POP in treated compartment or subsequent prolapse surgery) Furthermore definition treated compartment varies in each group. A includes all surgical sites B excludes sites where mesh was not utilised

objective failure rate or repeat prolapse surgery A 56/84 B 41/83

reoperation rates prolapse A 4/84 B 0/83

mesh exposure B 14/83

reoperation mesh exposure B 5/83

de novo dyspareunia A 3/29 B 3/37

de novo SUI A 8/89 B 8/81

cystotomy A 0 B 2

haematoma A 1 B 6

On POP-Q assessment both groups improved significantly with Gp B (mesh ) improving significantly more in Aa, Ba, Ap and Bp. Patients global Impresion of Improvement (PGII) were similar in both groups at 1 year.

Gp B demonstrated a significant postoperative improvement in domain of pain and incontinence

Sexual function following trocar guided mesh or vaginal native tissue repair in recurrent prolapse 2011 J Sexual medicine

Gp A 28 Gp B 32 who were sexually active pre surgery and completed PISQ pre and 12 months

pre                 post 

Total PISQ                                          

A:31.5(7.2)        34.7(7.2)                      

B: 35.0(5.7)       34.3(6.7)

behavioral/emotive

A 12.5(3.9)      12.7(3.5)                       

B: 13.8(3.1)     12.5(3.9)

physical

A 11.8(2.3)     13.3(2.1)                          

B: 13.1(3.1)    13.8(2.4)

Partner-related

A 7.8(1.9)    8.7(1.6)                               

B: 8.0(1.9)      7.8(2.2)

sexual function improved ( higher PISQ score) Gp A native tissue repair and deteriorated significantly in Gp B mesh post-surgery


NotesThe authors conclude that at 12months anatomic failure is lower in Gp B (prolift mesh ) as compared to Gp A. These findings are overshadowed by the two groups being significantly different prior to intervention on important findings. The lack of allocation concealment in the randomisation  process, variability and unorthodox definitions of success and non blinded surgeons reviewing their own surgery are significant limitations of the manuscript


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskcomputer generated

Allocation concealment (selection bias)High riskallocation concealment not described. Pre-operatively unfortunately group A is significantly different to the mesh group B as demonstrated by having greater degree prolapse at Ap, Bp and GH in table 4, having significantly higher number with ≥ stage II apical compartment prolapse in those in Table I undergoing prior apical surgery, 36% (16/45) in the non mesh versus 18% (10/56) in the mesh group (P= 0.04, OR 2.54) and finally prior sacral colpopexy was three times as frequent in the mesh group. Only the final anomaly is acknowledged and summatively these differences point to a systematic failure in the randomization process which potentially discredits the remaining findings

Blinding of participants and personnel (performance bias)
All outcomes
High risknon-blinded

Blinding of outcome assessment (detection bias)
All outcomes
High risknon-blinded reviewers: patient completed questionnaires

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskno statement

Other biasHigh riskfunded university research fund: all authors reported financial support from Ethicon company manufacturing product being evaluated by non-blinded reviewers

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aka 2004Unclear study design (participants having a hysterectomy are divided into 2 groups; not all participants had prolapse). Outcome was markers of tissue trauma (acute phase reactants).

Barber 2006Barber and colleagues compared two independent population cohorts. Arm one was the pessary group in which women were randomly allocated between two pessary types and arm two that underwent a surgical intervention. As patients were not randomly allocated between the pessary and surgery groups, this paper failed to meet the criteria of being a randomised controlled trial and was excluded.

Bergman 1989RCT on anterior colporrhaphy, Pereyra or Burch colposuspension, no data on pelvic organ prolapse given.

Biller 2008Biller and colleagues evaluated inclusion and exclusion of anal purse string suture to minimise contamination during prolapse surgery. This study was excluded from the review as it failed to evaluate pelvic organ prolapse surgical procedures.

Boccasanta 2004RCT on two transanal stapled techniques for outlet obstruction. Outlet obstruction caused not only by rectoceles but also by descending perineum and intussusception. Prolapse data not explicitly presented.

Carramao 2008aCarramao and colleagues compared vaginal hysterectomy with sacrospinous fixation (14) with hysteropexy and mesh pelvic floor repair (14) in women with stage 3 or more pelvic organ prolapse. Peri-operative data and objective success were recorded at 6 months and was identical between the groups. Although Camarro and collegues present the full and detailed results in a full manuscript in 2009 with 15 women in the hysterectomy and 16 in the hysteropexy group this paper was excluded due to the poor sample size and lack of data regarding functional outcomes, quality of life and complications. 

Choe 2000RCT on mesh versus vaginal wall sling for stress incontinence. Not all women had pelvic organ prolapse before the operation.

Colombo 1996bRCT on Burch colposuspension and paravaginal defect repair for stress incontinence, no report on treatment of associated anterior vaginal wall prolapse.

Cruikshank 1999RCT on three operations for prevention of enterocele. Study does not include treatment of prolapse.

Das 2004RCT on posterior intravaginal sling versus sacrospinous ligament fixation. Poster abstract only, very limited data, no results presented.

Debodinance 1993Comparison of two different procedures for stress incontinence and prolapse but no results on pelvic organ prolapse are reported post-operatively.

Del Roy 2010 abstractDel Roy compared in a single centre RCT anterior colporrhaphy versus NACA TC™, marcoporous polypropylene mesh, in surgical treatment to greater (grade III and IV) anterior vaginal prolapse. 78 women were included in this study. This study was excluded from this review due to paucity of data regarding distribution of patients within the the two procedures.The author only stated the overall success rate in percentage for the two groups (92% in the mesh versus 66% in the colporrhaphy group) without information of numbers within groups.

Di Palumbo 2003RCT non-balanced on stress urinary incontinence and urethro-cystocele grade 3-4 (Baden-Walker). Very limited prolapse data supplied (mean grading rather than numbers and percentages, failure rates not presented). No clear definition of success or failure.

Dixon 2010Dixon and colleagues compared in a randomised controlled trial the use of intermittent urethral catheterisation with indwelling suprapubic catheterization in women undergoing surgery for urodynamic stress incontinence or uterovaginal prolapse. 75 women were randomised. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

Duggan 2010Duggan and Barry assessed short-term results in a RCT comparing traditional colporrhaphy (n=16) and mesh repair (n=19) for anterior compartment prolapse. Due to a predefined decision that papers with less than 20 in each treatment group would not be included in the review the manuscript was excluded.

Glavind 2007Glavind and colleagues compared 3 hours and 24 hours post-operative catheter removal following pelvic organ prolapse surgery. While this study was very interesting, it was excluded from the review as it failed to evaluate pelvic organ prolapse surgical procedures.

Guvenal 2002Unclear study design (participants divided into 3 groups): vaginal hysterectomy + sacrospinous fixation; abdominal hysterectomy and sacral colpopexy; vaginal hysterectomy alone.

Heinonen 2011Heinonen and Nieminen evaluate outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) (n=14) or with concomitant posterior intravaginal slingplasty (IVS) (n=8) for uterovaginal or vaginal vault prolapse. Due to a predefined decision that papers with less than 20 in each treatment group would not be included in the review the manuscript was excluded.

Huang 2011Huang and colleagues compared in a RCT the duration of urethral catheterisation during and after pelvic reconstructive surgery. Ninety patients were randomly divided into 2, 3 and 4 days urinary catheterization groups. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as seperate subgroup analysis within the surgical management of pelvic organ prolapse review.

Juneja 2010Juneja and colleagues compared in a pilot randomised study hysterectomy (n=9) versus no hysterectomy (n=7) for uterine prolapse in conjunction with posterior infracococcygeal colpopexy. Due to a pre-defined decision that papers with less than 20 in each treatment group would not be included in the review the manuscript was excluded.

Kamilya 2010Kamilya and colleagues compared in a RCT short versus long-term catheterisation after uncomplicated vaginal prolapse surgery. Two hundred patients planned for vaginal prolapse surgery were included and randomly assigned into 1 day or 4 days catheterisation. The early removal of catheter seems more advantageous, with lower incidence of urinary tract infection and a shorter hospital stay although associated with an increased risk of re-catheterisation.

This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

Kokabi 2010Kokabi and colleagues compared in a RCT the best time of removal of the urinary catheter (Foley) after anterior or posterior colporrhaphy. One hundred and eighty nine patients who have been undergone colporrhaphy have been selected randomly and divided into three groups' as 1, 2 and 4 days of catheter removal. The authors suggest  that the best time to remove the urinary Foley catheter is the day four. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

Kringel 2010Kringel and collegues compared in a three arm RCT (indwelling urinary catheter for 24 hours or 96 hours  or  suprapubic catheter for 96hours) after a anterior colporrhaphy. The authors concluded that the optimal removal of an indwelling urinary cathether was after 24 hours. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

Kwon 2002Poster presentation at ICS 2002. Preliminary data, subgroup of an ongoing RCT on additional transvaginal sling for prevention of recurrent anterior vaginal wall prolapse.

Lopes 2010Lopes et al reported on a multi-centre RCT comparing sacrospinous ligament fixation with mono-filament polypropylene mesh kit (Nazca R®, Promedon®,Cordoba, Argentina) for stage 3-4 uterine prolapse. This study was excluded from the review as the sample size of 16 in each group was less than our pre-determined  group minimum of 20.

Lundarelli 2009Lundarelli and colleagues compared in a RCT polypropylene mesh versus site-specific repair in the treatment of stage III or IV or recurrent prolapse of the anterior vaginal wall prolapse. This study was excluded from the review as the sample size of 16 in each group was less than our pre-determined  group minimum of 20.

 

Martan 2010Martan and collegues compared in a three arm RTC the correlation between stress urinary incontinence or urgency and anterior compartment defect before and after surgery. Women were randomly assigned into anterior colporrhaphy group (n=18), individualised Gynemesh repair (n=33) or to Prolift anterior group (n=36). Incontinence specific issues will be reviewed in a subgroup review.

Mattos 2004Unclear study design (participants divided into 2 groups): following vaginal hysterectomy, the vault was repaired with (a), Richter's technique or (b) titanium staples to sacrospinous tendon.

Meschia 2007aMeschia and colleagues reported preliminary data comparing anterior and posterior mesh repair (Perigee and Apogee) without hysterectomy and fascial reconstructive surgery with hysterectomy in women with at least POP-Q stage 3 anterior compartment prolapse and stage 2 uterine descent. The abstract reports on 3 months outcomes with 21 women in the mesh group and 17 in non mesh group.

Due to the short follow-up time, small numbers and the preliminary nature of the study this abstract was excluded and we are awaiting the full data set which the authors were not able to supply at this time.

Mouritsen 2009Conference abstract only with limited sample size and data.

Quadri 1985Conference abstracts with unclear numbers and definitions, limited prolapse data.

Rane 2004RCT of 3 different operations (vaginal sacrospinous fixation SSF, posterior intravaginal slingplasty IVS, sacral colpopexy SCP (abdominal or laparoscopic)) but presented MRI findings of anatomical results only. SSF said to increase anatomical distortion relative to the other 2 operations.

Rudnicki 2010Rudnicki and colleagues compared in a RCT anterior colporrhaphy (n=40) versus Avaulta mesh repair for anterior compartment prolapse. Due to short follow up (3 months) this study was excluded from this review.

Segal 2007Segal and colleagues compared the feasibility of local anesthesia with IV sedation versus general anesthesia in women undergoing vaginal surgery for pelvic organ prolapse. This trial was excluded from the review as it failed to evaluate pelvic organ prolapse surgical procedures.

Svabik 2010Svabik and colleagues evaluated and quantified early and late changes in mesh length after anterior vaginal repair with implants (Gynemesh) with ultrasound. 35 patients were randomized in two groups with or without mesh augmented repair. The authors stated a tissue reaction expressed as shrinkage of mesh with 16-20%. This study was excluded from the review as the sample size of 17 and 18 respectively in each group was less than our predetermined  group minimum of 20 and the full article was in Czech.

Tincello 2009Tincello et al report a pilot randomised patient preference study comparing colposuspension or TVT for urinary incontinence at time of anterior repair for prolapse. Thirty-one women were recruited however only 4, 2 in each arm being randomised. Due to a pre-defined decision that papers with less than 20 in each treatment group would not be included in the review the manuscript was excluded.

Van Der Steen 2011Van der Steen compared in a prospective randomised control trial 1-day or 3-days suprapubic catheter in women undergoing anterior colporrhaphy to determine the optimal duration of catheterisation. One-hundred and seventy-nine patients were randomly allocated into the two groups. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

Weemhoff 2011Weemhoff and colleagues compared the number of temporary catheter replacements and urinary tract infections after indwelling catheterisation for 2 versus 5 days following an anterior colporrhaphy. Two hundred and forty-six patients were randomly assigned to 2 or 5 days of indwelling catheterisation. This study was excluded from this review. Catheter issues only at the time of prolapse surgery will be reviewed as separate subgroup analysis within the surgical management of pelvic organ prolapse review.

 
Characteristics of ongoing studies [ordered by study ID]
Cortesse 2010

Trial name or titleATHENA

MethodsRCT

Participantswomen with occult UI

InterventionsPOP+SUI surgery vs POP surgery alone

Outcomes

Starting date

Contact information

Notes

Glazener 2009

Trial name or titlePROSPECT (PROlapse Surgery: Pragmatic Evaluaiton and randomised Controlled Trials)

MethodsRCT

Participantswomen having prolapse surgery

Interventionsanterior and posterior repair (colporrhaphy) with or without non-absorbable or biological mesh inlay, or mesh kit

OutcomesProlapse symptoms (POP-SS); prolapse stage (POP-Q), economic outcomes

Starting date01 09 2009

Contact informationc.glazener@abdn.ac.uk

NotesHTA funded study in UK

van der Steen 2010

Trial name or titleCUPIDO 1 and CUPIDO 2

MethodsRCT

Participantswomen with SUI (CUPIDO 1) and women with occult SUI (CUPIDO 2)

InterventionsPOP+SUI surgery vs POP surgery alone

Outcomes

Starting date

Contact information

Notes

Verleyen 2004

Trial name or titlePorcine dermis versus Vicryl plug in Raz cystocele repair

Methods

Participants79 women (76 with concomitant prolapse)

InterventionsRCT, porcine dermis versus Vicryl

OutcomesUDI, IIQ, urinary urgency, recurrent cystocele

Starting date2003?

Contact informationDr P Verleyen, University Hospitals, Gassthuisberg

NotesAbstract of ongoing study reported ICS/IUGA Paris 2004

 
Comparison 1. Surgery for upper vaginal (vault or uterine) prolapse

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women with prolapse symptoms (subjective failure)6Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2169Risk Ratio (M-H, Random, 95% CI)0.52 [0.25, 1.09]

    1.2 abdominal sacro-hysteropexy versus vaginal hysterectomy plus anterior and/or posterior colporrhaphy at 1 year
182Risk Ratio (M-H, Random, 95% CI)3.2 [1.29, 7.92]

    1.3 abdominal sacro-hysteropexy versus vaginal hysterectomy plus anterior and/or posterior colporrhaphy at 8 years
184Risk Ratio (M-H, Random, 95% CI)2.6 [1.02, 6.65]

    1.4 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
166Risk Ratio (M-H, Random, 95% CI)0.67 [0.12, 3.73]

    1.5 laparoscopic sacral colpopexy vs total vaginal polypropylene mesh
1108Risk Ratio (M-H, Random, 95% CI)0.26 [0.03, 2.25]

    1.6 uterosacral colpopexy vs vaginal polypropylene mesh
159Risk Ratio (M-H, Random, 95% CI)2.36 [0.26, 21.42]

 2 Number of women unsatisfied with surgery2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Number of women who visited a physician after surgery because of pelvic floor symptoms1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 abdominal sacro-hysteropexy versus vaginal hysterectomy plus anterior and/or posterior colporrhaphy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Patient global impression Improvment PGI-I (very much better)147Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.65, 1.42]

    4.1 open versus laparoscopic sacral colpopexy
147Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.65, 1.42]

 5 Number of women with any prolapse (objective failure)8Risk Difference (M-H, Fixed, 95% CI)Totals not selected

    5.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy (failed)
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy (not improved)
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.3 abdominal sacral colpopexy vs vaginal McCall
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.4 cadaveric fascia lata (Tutoplast) vs polypropylene (Trelex)
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.5 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.6 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.7 uterosacral colpopexy versus vaginal polypropylene mesh
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.8 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1Risk Difference (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Number of women with recurrent vault/uterine prolapse (objective)8Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2169Risk Ratio (M-H, Random, 95% CI)0.23 [0.07, 0.77]

    6.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Random, 95% CI)0.31 [0.03, 2.91]

    6.3 cadavaric fascia lata (Tutoplast) vs polyprolylene (Trelex)
189Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    6.4 hysterectomy versus sacrospinous hystereopexy
165Risk Ratio (M-H, Random, 95% CI)0.16 [0.02, 1.20]

    6.5 High levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Random, 95% CI)1.17 [0.37, 3.72]

    6.6 sacral colpopexy versus high uterosacral colpopexy
1110Risk Ratio (M-H, Random, 95% CI)0.05 [0.00, 0.82]

 7 Vault distance from hymen (cm) POPQ point C after surgery5Mean Difference (IV, Fixed, 95% CI)Subtotals only

    7.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspensio
2358Mean Difference (IV, Fixed, 95% CI)0.41 [0.13, 0.69]

    7.2 laparoscopic sacral colpopexy versus total vaginal polpypropylene mesh kit
1108Mean Difference (IV, Fixed, 95% CI)-1.39 [-2.39, -0.39]

    7.3 cadaveric fascia at sacral colpopexy versus monofilament poypropylene mesh at sacral colpopexy
158Mean Difference (IV, Fixed, 95% CI)0.31 [-0.41, 1.03]

    7.4 open versus laparoscopic sacral colpopexy
147Mean Difference (IV, Fixed, 95% CI)0.0 [-0.74, 0.74]

 8 Total vaginal length (cm) after surgery3Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspensio
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.2 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.3 cadaveric fascia at sacral colpopexy versus monofilament poypropylene mesh at sacral co
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Number of women with recurrent cystocele (objective)4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
189Risk Ratio (M-H, Fixed, 95% CI)0.47 [0.12, 1.75]

    9.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.83, 3.27]

    9.3 High levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.57, 1.21]

 10 Objective anterior compartment prolapse after surgery3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    10.1 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.83, 3.27]

    10.2 hysterectomy versus sacrospinous hysteropexy
165Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.84, 1.97]

 11 Anterior vaginal wall distance from hymen (cm) POPQ point Ba after surgery4Mean Difference (IV, Fixed, 95% CI)Subtotals only

    11.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspensio
2296Mean Difference (IV, Fixed, 95% CI)0.44 [0.26, 0.63]

    11.2 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Mean Difference (IV, Fixed, 95% CI)-0.70 [-1.04, -0.36]

    11.3 cadaveric fascia at sacral colpopexy versus monofilament poypropylene mesh at sacral co
158Mean Difference (IV, Fixed, 95% CI)0.8 [0.20, 1.40]

 12 Number of women with recurrent rectocele (objective)4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    12.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
189Risk Ratio (M-H, Fixed, 95% CI)2.49 [0.71, 8.79]

    12.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.63 [0.55, 4.88]

    12.3 High levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.49, 2.31]

 13 Objective posterior compartment prolapse after surgery3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    13.1 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.63 [0.55, 4.88]

    13.2 hysterectomy versus sacrospinous hystereopexy
165Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.66, 4.09]

 14 Posterior vaginal wall distance from hymen (cm) POPQ point Bp after surgery4Mean Difference (IV, Random, 95% CI)Subtotals only

    14.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspensio
2296Mean Difference (IV, Random, 95% CI)0.09 [-0.69, 0.87]

    14.2 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Mean Difference (IV, Random, 95% CI)-0.70 [-1.03, -0.37]

    14.3 cadaveric fascia at sacral colpopexy versus monofilament poypropylene mesh at sacral co
158Mean Difference (IV, Random, 95% CI)0.20 [-0.11, 0.51]

 15 Number of women with post-operative stress urinary incontinence7Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    15.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2155Risk Ratio (M-H, Fixed, 95% CI)0.55 [0.32, 0.95]

    15.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.47, 3.74]

    15.3 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1299Risk Ratio (M-H, Fixed, 95% CI)1.85 [1.32, 2.60]

    15.4 High levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.18, 1.85]

    15.5 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.23, 1.18]

 16 Number of women with de novo stress incontinence3226Risk Ratio (M-H, Fixed, 95% CI)1.94 [1.10, 3.43]

    16.1 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)2.64 [0.11, 61.54]

    16.2 high levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)3.0 [1.47, 6.12]

    16.3 uterosacral colpopexy versus vaginal polypropylene mesh
165Risk Ratio (M-H, Fixed, 95% CI)0.48 [0.13, 1.78]

 17 Number of women with urgency, detrusor overactivity or overactive bladder6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    17.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
183Risk Ratio (M-H, Fixed, 95% CI)1.36 [0.78, 2.38]

    17.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.28 [0.67, 2.45]

    17.3 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1304Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.87, 1.59]

    17.4 high levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.65, 1.32]

    17.5 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)1.48 [0.84, 2.62]

 18 Number of women with de novo (new) urgency, detrusor overactivity or overactive bladder4527Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.84, 1.80]

    18.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
162Risk Ratio (M-H, Fixed, 95% CI)1.61 [0.68, 3.81]

    18.2 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1304Risk Ratio (M-H, Fixed, 95% CI)1.36 [0.87, 2.15]

    18.3 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)2.64 [0.11, 61.54]

    18.4 high levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.06, 1.32]

 19 Number of women with persistent voiding dysfunction1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    19.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 20 Number of women with new voiding dysfunction3236Risk Ratio (M-H, Fixed, 95% CI)1.94 [0.87, 4.32]

    20.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
175Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.07, 15.82]

    20.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)1.75 [0.36, 8.61]

    20.3 High levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)2.2 [0.82, 5.94]

 21 Number of women with de novo nocturia1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    21.1 High levator myorrhaphy vs uterosacral vag vault suspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 22 Postoperative voiding dysfunction symptoms2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    22.1 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)1.68 [0.81, 3.50]

 23 Number of women with faecal incontinence2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    23.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    23.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 24 Number of women with constipation3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    24.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
189Risk Ratio (M-H, Fixed, 95% CI)1.40 [0.64, 3.10]

    24.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Fixed, 95% CI)2.10 [0.66, 6.64]

 25 Number of women with de novo constipation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    25.1 High levator myorrhaphy vs uterosacral vag vault suspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 26 Number of women with obstructed defecation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    26.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 27 Postoperative dyspareunia6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    27.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
3106Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.18, 0.86]

    27.2 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
166Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 71.07]

    27.3 vaginal sacrospinous uterine suspension vs vaginal hysterectomy
1158Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.25, 3.76]

    27.4 High levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.51, 1.36]

 28 Women with de novo (new) postoperative dyspareunia3Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    28.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    28.2 High levator myorrhaphy vs uterosacral vag vault suspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    28.3 uterosacral colpopexy versus vaginal polypropylene mesh
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 29 Postoperative sexual function score (PISQ-12)2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    29.1 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    29.2 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 30 Blood loss (ml)7836Mean Difference (IV, Random, 95% CI)17.94 [-54.02, 89.90]

    30.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2213Mean Difference (IV, Random, 95% CI)-121.97 [-468.88, 224.94]

    30.2 abdominal sacrohysteropexy with Gore-Tex vs vaginal hysterectomy, vaginal repair, uterosacral ligament plicati
182Mean Difference (IV, Random, 95% CI)-4.0 [-22.91, 14.91]

    30.3 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
166Mean Difference (IV, Random, 95% CI)70.0 [56.07, 83.93]

    30.4 cadaveric fascia lata (Tutoplast) vs polypropylene (Trelex)
1100Mean Difference (IV, Random, 95% CI)218.0 [132.87, 303.13]

    30.5 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1322Mean Difference (IV, Random, 95% CI)-73.0 [-115.39, -30.61]

    30.6 open sacral colpopexy versus laparoscopic sacral colpopexy
153Mean Difference (IV, Random, 95% CI)184.0 [95.89, 272.11]

 31 Postoperative decrease in Hb (gm/dl)2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    31.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    31.2 Open sacral-colpopexy versus laparoscpic sacral-colpopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 32 Adverse effects13Risk Ratio (M-H, Random, 95% CI)Subtotals only

    32.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
3287Risk Ratio (M-H, Random, 95% CI)1.44 [0.40, 5.19]

    32.2 abdominal sacrohysteropexy with Gore-Tex vs vaginal hysterectomy, vaginal repair, uterosacral ligament plicati
182Risk Ratio (M-H, Random, 95% CI)1.2 [0.40, 3.62]

    32.3 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Risk Ratio (M-H, Random, 95% CI)0.73 [0.29, 1.82]

    32.4 cadaveric fascia lata (tutoplast) vs polypropylene (Trelex)
1100Risk Ratio (M-H, Random, 95% CI)0.68 [0.29, 1.59]

    32.5 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1322Risk Ratio (M-H, Random, 95% CI)0.99 [0.59, 1.68]

    32.6 vaginal sacrospinous uterine suspension vs vaginal hysterectomy
1158Risk Ratio (M-H, Random, 95% CI)4.23 [1.25, 14.25]

    32.7 abdominal sacral colpopexy vs vaginal McCall
147Risk Ratio (M-H, Random, 95% CI)7.29 [0.40, 133.82]

    32.8 High levator myorrhaphy vs uterosacral vag vault suspension
1229Risk Ratio (M-H, Random, 95% CI)0.05 [0.00, 0.87]

    32.9 Open sacral-colpopexy versus laparoscpic sacral-colpopexy
130Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    32.10 sacral colpopexy versus uterosacral colpopexy
1110Risk Ratio (M-H, Random, 95% CI)2.85 [0.97, 8.41]

 33 Operating time (minutes)11Mean Difference (IV, Fixed, 95% CI)Subtotals only

    33.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
3293Mean Difference (IV, Fixed, 95% CI)21.04 [12.15, 29.94]

    33.2 abdominal sacrohysteropexy with Gore-Tex vs vaginal hysterectomy, vaginal repair, uterosacral ligament plicati
182Mean Difference (IV, Fixed, 95% CI)-10.0 [-11.81, -8.19]

    33.3 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Mean Difference (IV, Fixed, 95% CI)7.58 [4.04, 11.13]

    33.4 cadaveric fascia lata (Tutoplast) vs polypropylene (Trelex)
1100Mean Difference (IV, Fixed, 95% CI)6.0 [-10.92, 22.92]

    33.5 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1322Mean Difference (IV, Fixed, 95% CI)-20.0 [-32.56, -7.44]

    33.6 Open sacral-colpopexy versus laparoscpic sacral-colpopexy
147Mean Difference (IV, Fixed, 95% CI)-12.0 [-31.00, 9.00]

    33.7 laparoscopic sacral colpopexy versus robotic sacral colpopexy
167Mean Difference (IV, Fixed, 95% CI)-66.0 [-88.99, -43.01]

    33.8 sacral colpopexy versus uterosacral colpoopexy
1110Mean Difference (IV, Fixed, 95% CI)22.0 [12.44, 31.56]

 34 Length of stay in hospital (days)8Mean Difference (IV, Fixed, 95% CI)Subtotals only

    34.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
3293Mean Difference (IV, Fixed, 95% CI)0.14 [-0.25, 0.53]

    34.2 abdominal sacrohysteropexy with Gore-Tex vs vaginal hysterectomy, vaginal repair, uterosacral ligament plicati
182Mean Difference (IV, Fixed, 95% CI)0.10 [-0.01, 0.21]

    34.3 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
2111Mean Difference (IV, Fixed, 95% CI)0.27 [-0.28, 0.82]

    34.4 Open sacral-colpopexy versus laparoscpic sacral-colpopexy
147Mean Difference (IV, Fixed, 95% CI)0.90 [0.12, 1.68]

    34.5 sacral colpoopexy versus uterosacral colpopexy
1110Mean Difference (IV, Fixed, 95% CI)1.6 [-0.67, 3.87]

 35 Time to return to normal activity ADL (days)2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    35.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    35.2 hysterectomy versus sacrospinous hystereopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 36 Days to return to work1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    36.1 hysterectomy versus sacrospinous hystereopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 37 Cost (US dollars)3Mean Difference (IV, Fixed, 95% CI)Subtotals only

    37.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2169Mean Difference (IV, Fixed, 95% CI)1333.95 [1027.24, 1640.65]

    37.2 laparoscopic sacral colpopexy versus robotic sacral colpopexy
168Mean Difference (IV, Fixed, 95% CI)-1954.0 [-3444.31, -463.69]

 38 Time to recurrence of prolapse (months)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    38.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 39 Women having further prolapse surgery11Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    39.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2169Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.19, 1.11]

    39.2 abdominal sacrohysteropexy with Gore-Tex vs vaginal hysterectomy, vaginal repair, uterosacral ligament plicati
182Risk Ratio (M-H, Fixed, 95% CI)9.0 [1.19, 67.85]

    39.3 hysterectomy versus sacrospinous hystereopexy
165Risk Ratio (M-H, Fixed, 95% CI)0.55 [0.11, 2.79]

    39.4 abdominal sacral colpopexy vs vaginal McCall
147Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.11]

    39.5 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.13, 5.68]

    39.6 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
1311Risk Ratio (M-H, Fixed, 95% CI)2.91 [0.60, 14.17]

    39.7 uterosacral colpopexy versus polypropylene mesh
165Risk Ratio (M-H, Fixed, 95% CI)0.14 [0.01, 2.58]

    39.8 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.80]

    39.9 sacral colpopexy versus high uterosacral ligament
1110Risk Ratio (M-H, Fixed, 95% CI)0.31 [0.09, 1.07]

    39.10 open versus laparoscopic sacral colpopexy
147Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.15, 6.25]

 40 Women having further continence surgery4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    40.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
3287Risk Ratio (M-H, Fixed, 95% CI)0.60 [0.21, 1.73]

    40.2 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.04, 3.22]

 41 Women having further related to primary surgery ( prolapse, continence or mesh complications)4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    41.1 abdominal sacral colpopexy vs vaginal sacrospinous colpopexy
2169Risk Ratio (M-H, Fixed, 95% CI)0.47 [0.23, 0.97]

    41.2 Abdominal sacro-hysteropexy versus vaginal hysterectomy plus anterior and/or posterior colporrhaphy at 8 years
184Risk Ratio (M-H, Fixed, 95% CI)1.83 [0.75, 4.50]

    41.3 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.26 [0.08, 0.87]

 42 mesh exposure2155Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.02, 1.16]

    42.1 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.02, 1.16]

    42.2 open versus laproscopic sacral colpopexy
147Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 43 surgery for mesh exposure1108Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 1.66]

    43.1 laparoscopic sacral colpopexy versus total vaginal polypropylene mesh kit
1108Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 1.66]

 44 Prolapse Quality of Life questionnaire (P-QOL)147Mean Difference (IV, Fixed, 95% CI)0.70 [-19.04, 20.44]

    44.1 open versus laparoscopic sacral colpopexy
147Mean Difference (IV, Fixed, 95% CI)0.70 [-19.04, 20.44]

 
Comparison 2. One method of anterior prolapse repair versus another surgical method

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women with prolapse symptoms (subjective failure)11Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1112Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.33, 2.81]

    1.2 traditional anterior colporraphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.00, 1.39]

    1.3 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
123Risk Ratio (M-H, Fixed, 95% CI)2.18 [0.23, 20.84]

   1.4 polypropylene mesh (Prolene soft) vs Pelvicol
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.5 anterior colporrhaphy vs armed transobturtor mesh
2555Risk Ratio (M-H, Fixed, 95% CI)1.77 [1.32, 2.37]

    1.6 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Fixed, 95% CI)2.0 [0.69, 5.80]

    1.7 fascial plication vs fascial plication with Pelvicol inlay
1201Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.62, 3.07]

    1.8 armed polypropylene mesh (Gynemesh) vs Pelvicol
1190Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.20, 4.73]

    1.9 anterior colporrhaphy versus any transvaginal polypropylene mesh
4712Risk Ratio (M-H, Fixed, 95% CI)1.64 [1.24, 2.16]

   1.10 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

   1.11 anterior colporrhaphy versus pericardial bovine collagen graft
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.12 anterior colporrhaphy with vivryl mesh versus vaginal paravaginal repair with vicryl mesh
169Risk Ratio (M-H, Fixed, 95% CI)0.34 [0.04, 3.14]

    1.13 anterior colporrhaphy versus repair with biological or permanent graft
5903Risk Ratio (M-H, Fixed, 95% CI)1.47 [1.16, 1.86]

    1.14 anterior colporrhaphy versus biological graft
2313Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.64, 2.30]

 2 number of women with posterior or apical prolapse2300Risk Ratio (M-H, Fixed, 95% CI)1.85 [1.01, 3.37]

 3 Severity of prolapse symptoms (measured using visual analogue scale)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 fascial plication vs Pelvicol overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Prolapse Quality of Life after surgery (P-QOL)2141Std. Mean Difference (IV, Fixed, 95% CI)0.09 [-0.24, 0.42]

    4.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
185Std. Mean Difference (IV, Fixed, 95% CI)0.22 [-0.21, 0.65]

    4.2 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Std. Mean Difference (IV, Fixed, 95% CI)-0.10 [-0.63, 0.42]

 5 Number of women with prolapse (objective failure any site)4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2138Risk Ratio (M-H, Fixed, 95% CI)0.66 [0.34, 1.27]

    5.2 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.37, 2.05]

    5.3 AC versus polypropylene mesh
140Risk Ratio (M-H, Fixed, 95% CI)6.0 [0.79, 45.42]

 6 Number of women with anterior prolapse / cystocele (objective failure)23Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 anterior colporrhaphy vs polypropylene mesh overlay
3181Risk Ratio (M-H, Random, 95% CI)3.01 [1.51, 5.98]

    6.2 traditional anterior colporrhaphy vs ultralateral anterior colporraphy
157Risk Ratio (M-H, Random, 95% CI)1.29 [0.84, 1.98]

    6.3 traditional anterior colporrhaphy vs anterior colporrhaphy + polyglactin mesh reinforcement
2202Risk Ratio (M-H, Random, 95% CI)1.41 [0.98, 2.05]

    6.4 ultralateral anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
150Risk Ratio (M-H, Random, 95% CI)0.94 [0.57, 1.54]

    6.5 traditional anterior colporrhaphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Random, 95% CI)0.09 [0.01, 0.64]

    6.6 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2138Risk Ratio (M-H, Random, 95% CI)0.60 [0.26, 1.42]

    6.7 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Random, 95% CI)0.96 [0.14, 6.57]

    6.8 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Random, 95% CI)1.17 [0.46, 2.98]

    6.9 fascial plication vs Porcine dermis Pelvicol overlay
3305Risk Ratio (M-H, Random, 95% CI)1.57 [1.05, 2.35]

    6.10 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1154Risk Ratio (M-H, Random, 95% CI)1.40 [0.80, 2.44]

    6.11 Vicryl vs Pelvicol
1125Risk Ratio (M-H, Random, 95% CI)3.22 [1.38, 7.52]

   6.12 polypropylene mesh (Prolene soft) vs Pelvicol
00Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    6.13 armed polypropylene mesh (Gynemesh) vs Pelvicol
1190Risk Ratio (M-H, Random, 95% CI)0.64 [0.43, 0.96]

    6.14 anterior colporrhaphy versus any transvaginal polypropylene mesh
7976Risk Ratio (M-H, Random, 95% CI)3.23 [2.55, 4.10]

    6.15 anterior colporrhaphy versus commercial transobturator polypropylene mesh kits
3549Risk Ratio (M-H, Random, 95% CI)3.83 [2.34, 6.26]

    6.16 anterior colporrhaphy versus self styled transobturator polypropylene mesh
2285Risk Ratio (M-H, Random, 95% CI)3.41 [2.05, 5.68]

    6.17 anterior colporrhaphy versus armed transobturator polypropylene mesh
5834Risk Ratio (M-H, Random, 95% CI)3.39 [2.62, 4.38]

    6.18 AC versus polypropylene mesh plus AC
3365Risk Ratio (M-H, Random, 95% CI)3.38 [2.14, 5.34]

    6.19 anterior colporrhaphy versus pericardial bovine collagen graft
144Risk Ratio (M-H, Random, 95% CI)1.57 [0.59, 4.23]

    6.20 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Risk Ratio (M-H, Random, 95% CI)2.95 [1.07, 8.17]

    6.21 anterior colporrhaphy with vivryl mesh versus vaginal para
169Risk Ratio (M-H, Random, 95% CI)1.24 [0.62, 2.47]

    6.22 AC verus polypropylene mesh repair without AC
4598Risk Ratio (M-H, Random, 95% CI)3.59 [2.38, 5.40]

    6.23 anterior colporrhaphy versus any biological graft
5490Risk Ratio (M-H, Random, 95% CI)1.56 [1.13, 2.14]

    6.24 anterior colporrhaphy versus repair with any graft ( synthetic, or allografts)
121455Risk Ratio (M-H, Random, 95% CI)2.82 [2.19, 3.62]

 7 Number of women with posterior prolapse / rectocele (objective failure)3Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 traditional anterior colporrhaphy vs anterior colporrhaphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 Gynemesh vs Pelvicol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.3 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Number of women with postoperative stress urinary incontinence4Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    8.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.2 anterior colporrhaphy versus armed transobturator polypropylene mesh
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.3 traditional anterior colporrhaphy vs abdominal Burch colposuspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.4 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Number of women with de novo (new) stress urinary incontinence9Risk Ratio (M-H, Random, 95% CI)Subtotals only

    9.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
4644Risk Ratio (M-H, Random, 95% CI)0.58 [0.36, 0.94]

    9.2 Gynemesh vs Pelvicol
1190Risk Ratio (M-H, Random, 95% CI)1.96 [0.18, 21.23]

    9.3 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Random, 95% CI)0.96 [0.25, 3.64]

    9.4 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2102Risk Ratio (M-H, Random, 95% CI)2.02 [0.08, 50.63]

    9.5 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Random, 95% CI)9.00 [1.23, 65.85]

 10 Number of women with urgency, detrusor overactivity or overactive bladder7749Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.53, 1.19]

    10.1 fascial plication vs fascial plication with Pelvicol overlay
1201Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.61, 2.14]

   10.2 Prolene soft vs Pelvicol
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    10.3 traditional anterior colporrhaphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.07, 16.27]

    10.4 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2138Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.20, 4.49]

    10.5 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.06, 14.96]

    10.6 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.04, 2.99]

    10.7 armed polypropylene mesh (Gynemesh) vs Pelvicol
1190Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.29, 1.07]

 11 De novo overactive bladder symptoms1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 12 Postoperative voiding dysfunction symptoms2349Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.79, 1.69]

    12.1 fascial plication vs fascial plication with Pelvicol overlay
1201Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.53, 1.94]

   12.2 prolene soft vs Pelvicol
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    12.3 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1148Risk Ratio (M-H, Fixed, 95% CI)1.26 [0.79, 2.01]

13 Urodynamic voiding dysfunction0Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

   13.1 Prolene soft vs pelvicol
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 14 Persistent voiding dysfunction8553Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.64, 1.36]

    14.1 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1105Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.73, 1.91]

    14.2 traditional anterior colporrhaphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    14.3 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2138Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.49, 2.26]

    14.4 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.00, 1.54]

    14.5 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.04, 2.99]

    14.6 anterior colporrhaphy versus transvaginal polypropylene mesh
140Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 69.52]

    14.7 anterior colporrhaphy versus SIS graft
150Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.11, 4.74]

 15 Time to return to spontaneous voiding (days)2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    15.1 fascial plication vs fascial plication with Pelvicol overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.2 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 16 Pelvic Floor Incontinence Questionnaire-7 after surgery1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    16.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 17 Number of women with worse bowel function / constipation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    17.1 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

   17.2 Prolene soft vs Pelvicol
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 18 Number of women with dyspareunia8Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    18.1 fascial plication vs fascial plication with Pelvicol overlay
195Risk Ratio (M-H, Fixed, 95% CI)0.70 [0.24, 2.05]

   18.2 Prolene Soft vs Pelvicol
00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    18.3 armed polypropylene mesh (Gynemesh) vs Pelvicol
1190Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.37, 1.80]

    18.4 traditional anterior colporrhaphy vs abdominal Burch colposuspension
147Risk Ratio (M-H, Fixed, 95% CI)6.78 [1.72, 26.81]

    18.5 cystopexy vs cystopexy + pubourethral ligament plication
147Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.04, 0.58]

    18.6 anterior colporrhaphy versus any vaginal polypropylene mesh
3457Risk Ratio (M-H, Fixed, 95% CI)0.87 [0.45, 1.69]

    18.7 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Risk Ratio (M-H, Fixed, 95% CI)1.16 [0.35, 3.89]

 19 Blood loss (ml)6Mean Difference (IV, Fixed, 95% CI)Subtotals only

    19.1 fascial plication vs Pelvicol overlay
2258Mean Difference (IV, Fixed, 95% CI)0.56 [-19.57, 20.70]

    19.2 anterior colporrhaphy versus armed transobturator polypropylene mesh
2569Mean Difference (IV, Fixed, 95% CI)-64.04 [-80.39, -47.69]

    19.3 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Mean Difference (IV, Fixed, 95% CI)-11.0 [-61.10, 39.10]

    19.4 anterior colporrhaphy versus repair with any graft (permanent or biological)
5871Mean Difference (IV, Fixed, 95% CI)-35.32 [-47.55, -23.09]

 20 Haemoglobin change2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    20.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    20.2 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 21 Number of women with postoperative complications7Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    21.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.2 traditional anterior colporrhaphy vs ultra-lateral anterior colporraphy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.3 traditional anterior colporrhaphy vs anterior colporrhaphy + polyglactin mesh reinforcement
2Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.4 ultralateral anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.5 traditional anterior colporrhaphy vs abdominal Burch colposuspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.6 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.7 cystopexy vs cystopexy + pubourethral ligament plication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    21.8 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

   21.9 Prolene soft vs Pelvicol
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 22 Mesh erosion10Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    22.1 anterior colporrhaphy versus polypropylene mesh
91110Risk Ratio (M-H, Fixed, 95% CI)0.07 [0.03, 0.18]

    22.2 armed polypropylene mesh (Gynemesh) vs Pelvicol
1190Risk Ratio (M-H, Fixed, 95% CI)12.73 [0.73, 222.87]

 23 Death1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    23.1 traditional anterior colporrhaphy vs ultralateral anterior colporrhaphy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    23.2 traditional anterior colporrhaphy vs anterior colporrhaphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    23.3 ultralateral anterior colporrhaphy vs anterior colporrhaphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 24 Operating time (minutes)6Mean Difference (IV, Fixed, 95% CI)Subtotals only

    24.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
2569Mean Difference (IV, Fixed, 95% CI)-18.57 [-21.16, -15.98]

    24.2 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Mean Difference (IV, Fixed, 95% CI)-19.0 [-28.68, -9.32]

    24.3 anterior colporrhaphy versus pelvicol overlay
157Mean Difference (IV, Fixed, 95% CI)-9.0 [-13.57, -4.43]

    24.4 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Mean Difference (IV, Fixed, 95% CI)-16.0 [-25.35, -6.65]

    24.5 anterior colporrhaphy versus any type of graft (biological or synthetic)
6776Mean Difference (IV, Fixed, 95% CI)-14.58 [-16.60, -12.55]

    24.6 anterior colporrhaphy versus polypropylene synthetic mesh repair
3613Mean Difference (IV, Fixed, 95% CI)-15.75 [-18.15, -13.35]

 25 Length of stay in hospital (days)6Mean Difference (IV, Fixed, 95% CI)Totals not selected

    25.1 fascial plication vs fascial plication with Pelvicol overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    25.2 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    25.3 cystopexy vs cystopexy + pubourethral ligament plication
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    25.4 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    25.5 anterior colporrhaphy versus transvaginal polypropylene mesh
2Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 26 Number of women having further prolapse surgery15Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    26.1 Vicryl vs Pelvicol
1125Risk Ratio (M-H, Fixed, 95% CI)3.05 [0.87, 10.73]

    26.2 anterior colporrhaphy versus transobturator mesh
6930Risk Ratio (M-H, Fixed, 95% CI)2.18 [0.93, 5.10]

    26.3 traditional anterior colporraphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    26.4 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
2138Risk Ratio (M-H, Fixed, 95% CI)0.41 [0.06, 2.71]

    26.5 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    26.6 anterior colporrhaphy versus pelvicol overlay
2107Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.11, 1.95]

    26.7 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    26.8 anterior colporrhaphy versus pericardial bovine collagen graft
144Risk Ratio (M-H, Fixed, 95% CI)1.57 [0.59, 4.23]

 27 Number of women having further incontinence surgery8Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    27.1 anterior colporrhaphy versus armed transobturator polypropylene mesh
4748Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.63, 2.63]

    27.2 traditional anterior colporrhaphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)3.18 [0.35, 29.08]

    27.3 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    27.4 prolapse repair + urethrovesical plication vs prolapse repair + needle colposuspension
1109Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    27.5 prolapse repair + urethrovesical endopelvic fascia repair vs prolapse repair + TVT
150Risk Ratio (M-H, Fixed, 95% CI)7.0 [0.38, 128.87]

 28 number of women with denovo dyspareunia5429Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.28, 1.32]

 29 Prolapse quality of life (PFDI-20)174Mean Difference (IV, Fixed, 95% CI)11.0 [-3.36, 25.36]

    29.1 anterior colporrhaphy versus polypropylene mesh kit
174Mean Difference (IV, Fixed, 95% CI)11.0 [-3.36, 25.36]

 30 quality of life (PFDI-7)168Mean Difference (IV, Fixed, 95% CI)9.0 [-3.86, 21.86]

    30.1 anterior colporrhaphy versus polypropylene mesh kit
168Mean Difference (IV, Fixed, 95% CI)9.0 [-3.86, 21.86]

 31 urinary distress inventory (UDI)1369Mean Difference (IV, Fixed, 95% CI)0.0 [-1.57, 1.57]

    31.1 anterior colporrhaphy versus transvaginal mesh
1369Mean Difference (IV, Fixed, 95% CI)0.0 [-1.57, 1.57]

 32 mesh erosion surgical correction6931Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.03, 0.29]

    32.1 anterior colporrhaphy versus transvaginal polypropylene mesh
6931Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.03, 0.29]

 33 new urinary stress incontinence postoperative5684Risk Ratio (M-H, Fixed, 95% CI)0.62 [0.40, 0.98]

    33.1 native tissue vaginal repair versus transvaginal polypropylene mesh
5684Risk Ratio (M-H, Fixed, 95% CI)0.62 [0.40, 0.98]

 34 cystotomy4647Risk Ratio (M-H, Fixed, 95% CI)0.19 [0.04, 1.06]

    34.1 anterior colporrhaphy versus transvaginal polypropylene mesh
4647Risk Ratio (M-H, Fixed, 95% CI)0.19 [0.04, 1.06]

 35 PISQ-12 Prolapse and Incontinence Sexual Questionnaire2463Mean Difference (IV, Fixed, 95% CI)0.08 [-0.18, 0.35]

 36 Point Ba144Mean Difference (IV, Fixed, 95% CI)0.9 [0.25, 1.55]

 37 Point Aa144Mean Difference (IV, Fixed, 95% CI)0.70 [0.25, 1.15]

 38 Point C144Mean Difference (IV, Fixed, 95% CI)0.60 [0.06, 1.14]

 39 Point Bp144Mean Difference (IV, Fixed, 95% CI)0.0 [-0.62, 0.62]

 40 POPQ Total vaginal length in cm144Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

 41 Subsequent surgery (prolapse, incontinence, mesh exposure, pain)91273Risk Difference (M-H, Random, 95% CI)-0.05 [-0.08, -0.03]

 
Comparison 3. One method of posterior prolapse repair versus another surgical method

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women with prolapse symptoms (subjective failure)4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 posterior vaginal colporrhaphy vs transanal repair
287Risk Ratio (M-H, Fixed, 95% CI)0.36 [0.13, 1.00]

    1.2 posterior vaginal colporrhaphy vs site specific repair
160Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.35, 3.93]

    1.3 posterior vaginal colporrhaphy vs site specific repair with porcine small intestine graft inlay
2181Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.45, 2.62]

 2 Number of women with prolapse (objective failure)5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 posterior vaginal colporrhaphy vs transanal repair (rectocele)
287Risk Ratio (M-H, Fixed, 95% CI)0.32 [0.07, 1.34]

    2.2 posterior vaginal colporrhaphy vs transanal repair (enterocele)
287Risk Ratio (M-H, Fixed, 95% CI)0.23 [0.07, 0.83]

    2.3 posterior vaginal colporrhaphy vs transanal repair (rectocele or enterocele))
287Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.09, 0.64]

    2.4 posterior vaginal colporrhaphy vs posterior colporrhaphy with mesh reinforcement for rectocele
1132Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.40, 3.19]

    2.5 posterior vaginal colporrhaphy vs site specific repair
155Risk Ratio (M-H, Fixed, 95% CI)0.64 [0.20, 2.03]

    2.6 posterior vaginal colporrhaphy vs site specific repair with porcine small intestine graft inlay
2191Risk Ratio (M-H, Fixed, 95% CI)0.47 [0.24, 0.94]

 3 Number of women with faecal incontinence after operation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 posterior vaginal colporrhaphy vs transanal repair
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Number of women with anal incontinence to flatus after operation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 posterior vaginal colporrhaphy vs transanal repair
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Number of women with obstructed defecation / constipation after surgery2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 posterior vaginal colporrhaphy vs transanal repair
265Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.37, 1.42]

 6 Number of women with sexual function not improved after operation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 posterior vaginal colporrhaphy vs transanal repair
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Number of women with dyspareunia4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    7.1 posterior vaginal colporrhaphy vs transanal repair
280Risk Ratio (M-H, Fixed, 95% CI)3.13 [0.87, 11.23]

    7.2 Posterior colporrhaphy vs site specific repair
142Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.71, 3.81]

    7.3 posterior colporrhaphy vs site specific augmented with porcine small intestine submucosa graft
2152Risk Ratio (M-H, Fixed, 95% CI)1.26 [0.59, 2.68]

 8 Blood loss (ml)2Mean Difference (IV, Fixed, 95% CI)Subtotals only

    8.1 posterior vaginal colporrhaphy vs transanal repair
287Mean Difference (IV, Fixed, 95% CI)79.38 [39.69, 119.08]

 9 Change in hematocrit1142Mean Difference (IV, Fixed, 95% CI)-0.48 [-1.64, 0.68]

    9.1 posterior colporrhaphy vs site specific repair
174Mean Difference (IV, Fixed, 95% CI)0.0 [-1.61, 1.61]

    9.2 posterior colporrhaphy vs site specific with porcine small intestine submucosa graft
168Mean Difference (IV, Fixed, 95% CI)-1.0 [-2.67, 0.67]

 10 Difference in haemoglobin1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    10.1 posterior vaginal colporrhaphy vs transanal repair
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 11 Postoperative narcotic (morphine) use1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    11.1 posterior vaginal colporrhaphy vs transanal repair
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 12 Number of women with postoperative complications3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    12.1 posterior vaginal colporrhaphy vs transanal repair
287Risk Ratio (M-H, Fixed, 95% CI)3.56 [0.80, 15.74]

    12.2 posterior vaginal colporrhaphy vs site specific repair
174Risk Ratio (M-H, Fixed, 95% CI)1.38 [0.87, 2.17]

    12.3 posterior vaginal colporrhaphy vs site specific repair with porcine small intestine graft inlay
168Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.69, 1.53]

 13 Persistent postoperative pain1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    13.1 posterior vaginal colporrhaphy vs transanal repair
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 14 Operating time (minutes)3Mean Difference (IV, Fixed, 95% CI)Subtotals only

    14.1 posterior vaginal colporrhaphy vs transanal repair
287Mean Difference (IV, Fixed, 95% CI)-3.64 [-7.43, 0.15]

    14.2 posterior colporrhaphy vs site specific repair
174Mean Difference (IV, Fixed, 95% CI)-1.0 [-32.22, 30.22]

    14.3 posterior colporrhaphy versus site specific and porcine small intestine submucosa graft
169Mean Difference (IV, Fixed, 95% CI)-19.0 [-49.68, 11.68]

 15 Length of stay in hospital (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    15.1 posterior vaginal colporrhaphy vs transanal repair
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 16 Number of women having further prolapse surgery1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    16.1 posterior vaginal colporrhaphy vs site specific repair
170Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.05, 5.90]

    16.2 posterior vaginal colporrhaphy vs site specific repair with porcine small intestine graft inlay
162Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.03, 2.66]

 17 rectocele size (centimetres) on defecography148Mean Difference (IV, Fixed, 95% CI)-1.14 [-1.96, -0.32]

 18 modified obstructed defecation syndrome patient questionnaire132Mean Difference (IV, Fixed, 95% CI)-5.10 [-9.63, -0.57]

 19 rectocele on examination (point Ap)152Mean Difference (IV, Fixed, 95% CI)-0.68 [-1.08, -0.28]

 
Comparison 6. No graft versus use of graft (synthetic mesh or biological graft)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women with prolapse symptoms (subjective failure)10Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 anterior and posterior colporrhaphy versus colporrhaphy with Vicryl mesh overlay
154Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.70, 1.31]

    1.2 fascial plication vs fascial plication with Pelvicol overlay
1201Risk Ratio (M-H, Fixed, 95% CI)1.37 [0.62, 3.07]

    1.3 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1112Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.33, 2.81]

    1.4 posterior colporrhaphy or site specific repair versus site specific repair with porcine intestine graft inlay
188Risk Ratio (M-H, Fixed, 95% CI)0.7 [0.28, 1.78]

    1.5 anterior or posterior repair versus repair with polypropylene mesh
6930Risk Ratio (M-H, Fixed, 95% CI)1.44 [1.15, 1.80]

    1.6 uterosacral vaginal repair versus polyprolene mesh kit
159Risk Ratio (M-H, Fixed, 95% CI)2.36 [0.26, 21.42]

    1.7 native tissue repair versus repair with any graft ( synthetic, or allografts)
91331Risk Ratio (M-H, Fixed, 95% CI)1.36 [1.10, 1.67]

    1.8 colporrhaphy vs biological graft repair
3401Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.61, 1.75]

    1.9 native tissue versus combined total or anterior or posterior vaginal mesh
2218Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.59, 1.93]

 2 Prolapse symptom score at 1 to 5 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 anterior and posterior colporrhaphy versus colporrhaphy with Vicryl mesh overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Quality of life (VAS) for severity of prolapse symptoms2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 fascial plication vs fascial plication with Pelvicol overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 anterior or posterior repair alone versus repair with polyglactin (Vicryl) mesh inlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Number of women with anterior prolapse / cystocele (objective failure)6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 traditional or ultralateral anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
2226Risk Ratio (M-H, Fixed, 95% CI)1.39 [1.02, 1.90]

    4.2 fascial plication vs fascial plication with Pelvicol overlay
2230Risk Ratio (M-H, Fixed, 95% CI)2.09 [1.08, 4.06]

    4.3 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1154Risk Ratio (M-H, Fixed, 95% CI)1.40 [0.80, 2.44]

    4.4 Anterior colporrhaphy versus porcine Small Intensine Submucosa (SIS)
156Risk Ratio (M-H, Fixed, 95% CI)2.95 [1.07, 8.17]

 5 Objective failure all sites4420Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.07, 1.64]

    5.1 anterior and posterior colporrhaphy versus colporrhaphy with Vicryl mesh overlay
166Risk Ratio (M-H, Fixed, 95% CI)1.88 [0.37, 9.58]

    5.2 anterior and posterior colporrhaphy versus colporrhaphy with polypropylene mesh overlay
2289Risk Ratio (M-H, Fixed, 95% CI)1.38 [1.07, 1.79]

    5.3 uterosacral colpopexy versus vaginal polypropylene mesh
165Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.79, 1.58]

 6 Number of women with posterior prolapse / rectocele (objective failure)2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 traditional anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 posterior colporrhaphy or site specific repair versus site specific repair with porcine intestine graft inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Objective failure, any site, no mesh versus any mesh206003Risk Ratio (M-H, Random, 95% CI)1.95 [1.66, 2.28]

    7.1 No mesh versus any absorbable synthetic mesh
3292Risk Ratio (M-H, Random, 95% CI)1.35 [0.94, 1.95]

    7.2 No mesh versus any biological mesh
6565Risk Ratio (M-H, Random, 95% CI)1.35 [0.74, 2.46]

    7.3 No mesh versus any non-absorbable polypropylene mesh
111155Risk Ratio (M-H, Random, 95% CI)2.45 [1.64, 3.67]

    7.4 native tissue repair versus any graft ( biological, absorbable or permanent mesh)
181912Risk Ratio (M-H, Random, 95% CI)1.84 [1.37, 2.46]

    7.5 native tissue repair versus any transobturator mesh
7848Risk Ratio (M-H, Random, 95% CI)2.47 [1.46, 4.18]

    7.6 native tissue repair versus self-styled transobturator mesh
2285Risk Ratio (M-H, Random, 95% CI)3.41 [2.05, 5.68]

    7.7 native tissue repair versus commercial transobturator mesh kit
5563Risk Ratio (M-H, Random, 95% CI)2.22 [1.22, 4.03]

    7.8 native tissue versus combined total or anterior or posterior vaginal mesh
3383Risk Ratio (M-H, Random, 95% CI)1.39 [0.97, 2.00]

 8 Number of women having repeat prolapse surgery15Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    8.1 anterior or posterior repair alone versus repair with polyglactin (Vicryl) mesh inlay
166Risk Ratio (M-H, Fixed, 95% CI)1.88 [0.37, 9.58]

    8.2 native tissue vaginal repair versus transvaginal polpropylene mesh kit
101365Risk Ratio (M-H, Fixed, 95% CI)1.95 [1.00, 3.81]

    8.3 native tissue vaginal repair versus biological graft repair
5306Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.41, 1.63]

    8.4 native tissue versus combined total or anterior or posterior vaginal mes
3383Risk Ratio (M-H, Fixed, 95% CI)1.62 [0.54, 4.85]

 9 Number of women with urgency, detrusor overactivity or overactive bladder1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 fascial plication vs fascial plication with Pelvicol overlay
1201Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.61, 2.14]

 10 Number of women with postoperative urinary incontinence2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    10.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    10.2 anterior or posterior repair alone versus repair with polyglactin (Vicryl) mesh inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 11 Postoperative voiding dysfunction symptoms2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    11.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    11.2 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 12 Persistent voiding dysfunction1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    12.1 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 13 Number of women with dyspareunia6Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    13.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.2 posterior colporrhaphy or site specific repair versus site specific repair with porcine intestine graft inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.3 anterior and posterior colporrhaphy versus Anterior and posterior polypropylene Mesh overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.4 anterior or posterior repair alone versus repair with polyglactin (Vicryl) mesh inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.5 native tissue vaginal repair versus transvaginal polpropylene mesh
2Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 14 De novo dyspareunia9851Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.86, 1.77]

    14.1 anterior and posterior colporrhaphy versus Anterior and posterior polypropylene Mesh overlay
2188Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.64, 2.36]

    14.2 native tissue repair vs mesh repair
9663Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.80, 1.90]

 15 Number of women with postoperative complications4Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    15.1 fascial plication vs fascial plication with Pelvicol overlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.2 traditional or ultralateral anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
2Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.3 posterior colporrhaphy or site specific repair versus site specific repair with porcine intestine graft inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 16 Death2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    16.1 traditional or ultralateral anterior colporraphy vs anterior colporraphy + polyglactin mesh reinforcement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    16.2 anterior or posterior repair alone versus repair with polyglactin (Vicryl) mesh inlay
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 17 Length of stay in hospital (days)3Mean Difference (IV, Fixed, 95% CI)Totals not selected

    17.1 fascial plication vs fascial plication with Pelvicol overlay
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    17.2 native tissue versus transvaginal polypropylene mesh
2Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 18 new urinary stress incontinence postoperative4326Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.96, 1.19]

    18.1 native tissue vaginal repair versus transvaginal polpropylene mesh kit
4326Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.96, 1.19]

 19 mesh erosion131998Risk Ratio (M-H, Fixed, 95% CI)0.06 [0.03, 0.12]

    19.1 native tissue vaginal repair versus transvaginal polypropylene mesh
131615Risk Ratio (M-H, Fixed, 95% CI)0.06 [0.03, 0.14]

    19.2 native tissue versus combined total or anterior or posterior vaginal mesh
3383Risk Ratio (M-H, Fixed, 95% CI)0.04 [0.01, 0.21]

 20 surgery for mesh erosion3383Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.02, 0.42]

    20.1 native tissue versus combined total or anterior or posterior vaginal mesh
3383Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.02, 0.42]

 21 cystotomy61361Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.09, 0.59]

    21.1 native tissue versus combined total or anterior or posterior vaginal mesh
4427Risk Ratio (M-H, Fixed, 95% CI)0.26 [0.06, 1.19]

    21.2 native tissue vaginal repair versus transvaginal polypropylene mesh
5934Risk Ratio (M-H, Fixed, 95% CI)0.22 [0.07, 0.70]

 22 Patient global impression of improvement (PGI-I) very much or much better2235Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.87, 1.23]

    22.1 native tissue vaginal repair versus transvaginal polpropylene mesh kit
2235Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.87, 1.23]

 23 PISQ-12 Prolapse and Incontinence Sexual Questionnaire4588Mean Difference (IV, Fixed, 95% CI)0.09 [-0.17, 0.36]

 24 number undergoing further continence surgery5808Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.59, 2.33]

 25 Subsequent surgery (prolapse, incontinence, mesh exposure, pain)3383Risk Ratio (M-H, Fixed, 95% CI)1.09 [1.02, 1.15]

 26 Blood loss (ml)5Mean Difference (IV, Fixed, 95% CI)Subtotals only

    26.1 fascial plication vs Pelvicol overlay
2258Mean Difference (IV, Fixed, 95% CI)0.56 [-19.57, 20.70]

    26.2 native tissue versus armed transobturator polypropylene mesh
2569Mean Difference (IV, Fixed, 95% CI)-64.04 [-80.39, -47.69]

    26.3 native tissue versus repair with any graft (permanent or biological)
5871Mean Difference (IV, Fixed, 95% CI)-35.32 [-47.55, -23.09]

 27 Point Ba144Mean Difference (IV, Fixed, 95% CI)0.9 [0.25, 1.55]

 28 Point Aa144Mean Difference (IV, Fixed, 95% CI)0.70 [0.25, 1.15]

 29 Point C144Mean Difference (IV, Fixed, 95% CI)0.60 [0.06, 1.14]

 30 Point Bp144Mean Difference (IV, Fixed, 95% CI)0.0 [-0.62, 0.62]

 31 POPQ Total vaginal length in cm144Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

 
Comparison 7. One type of graft (synthetic mesh or biological graft) versus another type of graft

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

1 Number of women with prolapse symptoms (subjective failure)0Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

   1.1 Prolene soft vs Pelvicol
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Number of women with anterior prolapse / cystocele (objective failure)2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Vicryl vs Pelvicol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Number of women having further prolapse surgery2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Vicryl vs Pelvicol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Stress urinary incontinence de novo1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Increased daytime urinary frequency post-op1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Dyspareunia post-op1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Vaginal mesh erosion1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

   7.1 Monofilament Polypropylene Mesh (Prolene soft) versus Porcine Dermis Graft
0Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 armed polypropylene mesh versus porcine dermis graft
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Hospital stay (days)1190Mean Difference (IV, Fixed, 95% CI)-0.40 [-0.90, 0.10]

    8.1 Monofilament Polypropylene Mesh versus Porcine Dermis Graft
1190Mean Difference (IV, Fixed, 95% CI)-0.40 [-0.90, 0.10]

 
Comparison 8. One suture type versus another type of suture

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women with prolapse symptoms up to 1 year (subjective failure)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Number of women with prolapse symptoms at 1 to 5 years (subjective failure)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Prolapse symptom score up to 1 year1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Prolapse symptom score at 1 to 5 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Quality of life score due to prolapse (VAS) up to 1 year1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Quality of life score due to prolapse (VAS) at 1 to 5 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Objective failure all sites1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Number of women with urinary incontinence at 1 to 5 years1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    8.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 ICI Urinary symptom score at 1 to 5 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    9.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 10 Number of women with dyspareunia at 1 to 5 years1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    10.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 11 Death1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    11.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 12 Number of women having repeat prolapse surgery1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    12.1 Polydioxanone (PDS) suture versus polyglactin (Vicryl) suture
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 9. Prolapse surgery and bladder function

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 number with de novo ( new) stress urinary incontinence152731Risk Ratio (M-H, Random, 95% CI)1.16 [0.86, 1.56]

    1.1 sacral colpopexy versus vaginal colpopexy
146Risk Ratio (M-H, Random, 95% CI)0.27 [0.06, 1.15]

    1.2 cystopexy versus cystopexy with pubourethral ligament plication
1102Risk Ratio (M-H, Random, 95% CI)0.96 [0.25, 3.64]

    1.3 prolapse repair with urethrovesical plication versus prolapse repair with needle suspension
2102Risk Ratio (M-H, Random, 95% CI)2.02 [0.08, 50.63]

    1.4 sacral colpopexy versus sacral colpopexy and colposuspension
2364Risk Ratio (M-H, Random, 95% CI)1.04 [0.38, 2.82]

    1.5 prolapse repair versus prolapse repair +suburethral tape (TVT)
2387Risk Ratio (M-H, Random, 95% CI)2.44 [0.75, 7.95]

    1.6 prolapse surgery without continence surgery versus prolapse surgery with continence surgery
6832Risk Ratio (M-H, Random, 95% CI)1.81 [1.21, 2.71]

    1.7 native tissue repair versus armed transobturator polypropylene mesh
6898Risk Ratio (M-H, Random, 95% CI)0.67 [0.48, 0.93]

 2 Number with de novo (new) stress urinary incontinence (objective)4522Risk Ratio (M-H, Random, 95% CI)1.81 [1.02, 3.22]

    2.1 prolapse repair +urethrovesical plication versus prolapse repair + needle suspension
183Risk Ratio (M-H, Random, 95% CI)1.19 [0.75, 1.91]

    2.2 Prolapse repair without TVT versus prolapse repair and suburethral tape
3439Risk Ratio (M-H, Random, 95% CI)3.72 [0.91, 15.20]

 3 Further continence surgery91491Risk Ratio (M-H, Fixed, 95% CI)4.04 [2.69, 6.07]

    3.1 Prolapse surgery without continence surgery versus prolapse surgery with continence surgery
3456Risk Ratio (M-H, Fixed, 95% CI)1.97 [1.20, 3.23]

    3.2 prolapse surgery ( continent women) versus prolapse surgery with TVT
152Risk Ratio (M-H, Fixed, 95% CI)2.79 [0.12, 65.38]

    3.3 cystopexy versus cystopexy with pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.4 sacral colpopexy versus vaginal sacrospinous colpopexy
2207Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.28, 3.95]

    3.5 prolapse repair + urethrovesical plication versus prolapse repair and needle suspension
173Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.6 prolapse surgery (incontinent women) +urethrovesical plication versus prolapse surgery and suburethral tape (TVT)
1181Risk Ratio (M-H, Fixed, 95% CI)99.12 [6.21, 1581.10]

    3.7 Prolpase repair +urethrovesical fascial repair versus prolpase repair +TVT
3420Risk Ratio (M-H, Fixed, 95% CI)6.37 [1.46, 27.72]

 4 Number with denovo (new) urgency, detrusor overactivity or overactive bladder101005Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.80, 1.55]

    4.1 sacral colpopexy versus vaginal colpopexy
162Risk Ratio (M-H, Fixed, 95% CI)1.61 [0.68, 3.81]

    4.2 cystopexy versus cystopexy with pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.06, 14.96]

    4.3 prolapse repair with urethrovesical plication versus prolapse repair with needle suspension
2138Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.20, 4.49]

    4.4 Prolene soft versus Pevicol
137Risk Ratio (M-H, Fixed, 95% CI)0.47 [0.05, 4.78]

    4.5 prolapse repair versus prolapse repair +suburethral tape (TVT)
150Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.04, 2.99]

    4.6 native tissue repair versus transvaginal mesh
1151Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.43, 2.77]

    4.7 abdominal sacrocolpopexy alone vs abdominal sacrocolpopexy with Burch colposuspension
1304Risk Ratio (M-H, Fixed, 95% CI)1.36 [0.87, 2.15]

    4.8 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)2.64 [0.11, 61.54]

    4.9 high levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)0.29 [0.06, 1.32]

 5 Longterm voiding dysfunction121209Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.67, 1.28]

    5.1 sacral colpopexy versus vaginal colpopexy
175Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.07, 15.82]

    5.2 cystopexy versus cystopexy with pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.00, 1.54]

    5.3 prolapse repair with urethrovesical plication versus prolapse repair with needle suspension
2138Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.49, 2.26]

    5.4 High levator myorrhaphy vs uterosacral vag vault suspension
1116Risk Ratio (M-H, Fixed, 95% CI)2.2 [0.82, 5.94]

    5.5 prolapse repair versus prolapse repair +suburethral tape (TVT)
2368Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.04, 1.12]

    5.6 vaginal sacrospinous colpopexy vs posterior intravaginal slingplasty
145Risk Ratio (M-H, Fixed, 95% CI)1.75 [0.36, 8.61]

    5.7 anterior colporrhaphy vs cadaveric fascia lata (Tutoplast)
1105Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.73, 1.91]

    5.8 traditional anterior colporraphy vs abdominal Burch colposuspension
168Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.9 cystopexy vs cystopexy + pubourethral ligament plication
1102Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.00, 1.54]

    5.10 anterior colporrhaphy versus transvaginal polypropylene mesh
140Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 69.52]

    5.11 anterior colporrhaphy versus SIS graft
150Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.11, 4.74]

 6 Number with new or denovo SUI who had occult SUI pre-operatively4242Risk Ratio (M-H, Random, 95% CI)2.61 [0.81, 8.42]

 7 post prolapse surgery SUI objective101582Risk Ratio (M-H, Random, 95% CI)1.92 [1.23, 3.00]

    7.1 Prolapse surgery with and without continence surgery
81010Risk Ratio (M-H, Random, 95% CI)1.63 [1.07, 2.47]

    7.2 Prolapse surgery no TVT versus prolapse surgery with TVT
152Risk Ratio (M-H, Random, 95% CI)8.33 [1.14, 61.15]

    7.3 sacral colpopexy without colposuspension in continent women versus sacral colpopexy + colposuspension
1292Risk Ratio (M-H, Random, 95% CI)1.83 [1.29, 2.61]

    7.4 Prolapse surgery alone (incontinent women) versus prolapse surgery with continence surgery
2228Risk Ratio (M-H, Random, 95% CI)3.29 [0.09, 115.01]

 8 Incontinence Impact Questionnaire IIQ post147Mean Difference (IV, Fixed, 95% CI)0.0 [-1.96, 1.96]

    8.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)0.0 [-1.96, 1.96]

 9 Urinary Distress Inventory (UDI-6)2358Mean Difference (IV, Fixed, 95% CI)0.35 [-1.06, 1.76]

    9.1 sacral colpopexy without colposuspension (continent women) versus sacral colpopexy with colposuspension
1311Mean Difference (IV, Fixed, 95% CI)10.7 [2.93, 18.47]

    9.2 sacral colpoopexy without colpopsuspension ( incontinent women) versus sacral colpopexy with colpsuspension
147Mean Difference (IV, Fixed, 95% CI)0.0 [-1.43, 1.43]

 10 Bothersome SUI (PFDI) post-operative2483Risk Ratio (M-H, Fixed, 95% CI)4.74 [3.05, 7.37]

    10.1 Prolapse surgery without TVT versus prolapse surgery with TVT
1181Risk Ratio (M-H, Fixed, 95% CI)15.50 [5.90, 40.72]

    10.2 sacral colpopexy without colpsuspension versus sacral colpopexy with colposuspension
1302Risk Ratio (M-H, Fixed, 95% CI)2.18 [1.29, 3.67]

 11 satisfaction (VAS 0-10)147Mean Difference (IV, Fixed, 95% CI)1.0 [0.07, 1.93]

    11.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)1.0 [0.07, 1.93]

 12 Pelvic Floor Incontinence questionnaire (PFIQ) bladder domain1311Mean Difference (IV, Fixed, 95% CI)2.90 [0.16, 5.64]

    12.1 sacral colpopexy without colpsuspension versus sacral colpopexy with colposuspension
1311Mean Difference (IV, Fixed, 95% CI)2.90 [0.16, 5.64]

 13 Pelvic organ Prolapse/Urinary incontinence Sexual Function Questionnaire (PISQ)1194Mean Difference (IV, Fixed, 95% CI)0.10 [-1.38, 1.58]

    13.1 Sacral colpopexy without continence surgery versus sacral colpopexy with colposuspension
1194Mean Difference (IV, Fixed, 95% CI)0.10 [-1.38, 1.58]

 14 further Prolapse surgery1311Risk Ratio (M-H, Fixed, 95% CI)2.91 [0.60, 14.17]

    14.1 Sacral colpopexy with colposuspension versus sacral colpopexy with colposuspension
1311Risk Ratio (M-H, Fixed, 95% CI)2.91 [0.60, 14.17]

 15 De novo Stress urinary incontinence women with negative preoperative stress test2455Risk Ratio (M-H, Random, 95% CI)1.68 [1.22, 2.32]

 16 blood loss (mls)1311Mean Difference (IV, Fixed, 95% CI)-70.0 [-113.02, -26.98]

    16.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
1311Mean Difference (IV, Fixed, 95% CI)-70.0 [-113.02, -26.98]

 17 POPQ point Aa147Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

    17.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

 18 Point Ap147Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

    18.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)0.0 [-0.43, 0.43]

 19 POP-Q Point Ba2296Std. Mean Difference (IV, Fixed, 95% CI)0.48 [0.25, 0.71]

    19.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
2296Std. Mean Difference (IV, Fixed, 95% CI)0.48 [0.25, 0.71]

 20 POPQ point Bp2296Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.23, 0.21]

    20.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
2296Mean Difference (IV, Fixed, 95% CI)-0.01 [-0.23, 0.21]

 21 POPQ point C2358Mean Difference (IV, Fixed, 95% CI)0.41 [0.13, 0.69]

    21.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
2358Mean Difference (IV, Fixed, 95% CI)0.41 [0.13, 0.69]

 22 POPQ point D147Mean Difference (IV, Fixed, 95% CI)-0.5 [-0.86, -0.14]

    22.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)-0.5 [-0.86, -0.14]

 23 Total vaginal length (TVL cm)147Mean Difference (IV, Fixed, 95% CI)0.5 [-0.09, 1.09]

    23.1 sacral colpopexy without colposuspension versus sacral colpopexy with colposuspension
147Mean Difference (IV, Fixed, 95% CI)0.5 [-0.09, 1.09]

 24 Pelvic Floor Urinary Impact Questionnaire (PFUIQ)1301Mean Difference (IV, Fixed, 95% CI)2.30 [-13.21, 17.81]

 25 Number with persisting stress urinary incontinence after prolpase and continence surgery4312Risk Ratio (M-H, Fixed, 95% CI)3.42 [2.37, 4.92]

    25.1 Anterior colporrhaphy versus colposuspension
167Risk Ratio (M-H, Fixed, 95% CI)2.19 [1.15, 4.15]

    25.2 Anterior colporrhaphy versus biological graft
117Risk Ratio (M-H, Fixed, 95% CI)1.79 [0.73, 4.36]

    25.3 prolaspe surgery without TVT versus prolapse surgery with TVT
1181Risk Ratio (M-H, Fixed, 95% CI)15.50 [5.90, 40.72]

    25.4 sacral colpopexy/hysteropexy no colposuspension versus sacral colpopexy/ hysteropexy with colposuspension
147Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.39, 1.35]

 
Table 1. Graft erosion

Number with erosionTotal number of women

Polyglactin (Vicryl, absorbable synthetic)

Allahdin 2008232

Sand 2001073

Biological

(porcine, Pelvicol)

Meschia 2007198

Non-absorable synthetic polypropylene

Ali 2006 abstract346

Carey 2009462

Menefee 2011528

Nguyen 2008237

Nieminen 200818104

Sivaslioglu 2008343

 
Table 2. Polypropylene mesh erosion

Ali 2006346

Carey 2009 NEW462

Iglesia 2010 NEW532

Menefee 2011528

Nguyen 2008237

Nieminen 200818104

Sivaslioglu 2008343

Thijs 2010 NEW948

Vollebregt 2010 NEW253

Withagen 2011 NEW1483

Subtotal (95% CI)536

Total events65