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Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women

  1. Reuben Olugbenga Ayeleke1,
  2. E. Jean C Hay-Smith2,*,
  3. Muhammad Imran Omar1

Editorial Group: Cochrane Incontinence Group

Published Online: 20 NOV 2013

Assessed as up-to-date: 28 FEB 2013

DOI: 10.1002/14651858.CD010551.pub2


How to Cite

Ayeleke RO, Hay-Smith EJC, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD010551. DOI: 10.1002/14651858.CD010551.pub2.

Author Information

  1. 1

    University of Aberdeen, Academic Urology Unit, Aberdeen, UK

  2. 2

    University of Otago, Rehabilitation Teaching and Research Unit, Department of Medicine, Wellington, New Zealand

*E. Jean C Hay-Smith, Rehabilitation Teaching and Research Unit, Department of Medicine, University of Otago, Wellington, New Zealand. jean.hay-smith@otago.ac.nz.

Publication History

  1. Publication Status: New
  2. Published Online: 20 NOV 2013

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Characteristics of included studies [ordered by study ID]
Burgio 2010a

Methods2-arm randomised controlled trial, parallel design


Participants64 women with urgency predominant incontinence


InterventionsA: Drug therapy alone group (n = 32). Individuals in this group received oxybutynin 5 mg daily with dose gradually increased during visits to the maximum level the individual could tolerate (dose range: 5 to 30 mg)

B: Behavioural therapy + drug therapy (n = 32): participants in this group received drug therapy as described above and behavioural therapy. Behavioural therapy included PFMT and urge suppression strategies. PFMT consisted of 3 sessions of 15 exercises daily (total of 45 exercises). During each session, participants were instructed to contract for 10 seconds and relax for another 10 seconds (maximum duration of 10 seconds was achieved on a gradual basis). They were also taught the skills on urge suppression strategies


Outcomes1. Patient global perception of improvement: this was measured using the Global Perception of Improvement rating. Success was defined as the proportion of participants who felt 'much better' at the end of the treatment

At 8 weeks:

A: 28/31; B: 21/27 

2. Condition-specific quality of life: assessed using the Incontinence Impact Questionnaire and Urogenital Distress Inventory (reported as mean score and SD; details of data not reported)

3. Patient satisfaction with treatment outcome: success was defined as the proportion of participants who were completely satisfied with the treatment outcome. It was assessed using the Patient Satisfaction Questionnaire

At 8 weeks:

A: 27/31; B: 21/27

4. Frequency of incontinence episodes per week: mean (SD) of incontinence episodes frequency was assessed at endpoint using the 7-day bladder diary

At 8 weeks:

A: 2.0 (4.9), n = 30: B: 2.4 (6.2), n = 27

At 12 months:

A: 1.7 (3.9), n = 27; B: 4.5 (11.4), n = 22

5. Frequency of micturition per 24 hours (in mean and SD)

At 8 weeks:

A: 8.2 (1.9), n = 31; B: 8.4 (3.0), n = 27

6. Volumes of urine voided per 24 hours (in mean and SD)

At 8 weeks:

A: 256.7 (86.7), n = 31; B: 240.4 (129.1), n = 27


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStated as "stratified block randomisation". Exact process not specified

Allocation concealment (selection bias)Unclear riskIt was not stated whether or not the allocations were concealed

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskCompleted questionnaires were submitted in sealed envelopes and given to the nurses who administered the intervention. However, it is not specified whether the same or different nurses assessed the outcomes

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk5/64 dropped out of the trial: A 1/32; B 4/32. Reasons not specified

Selective reporting (reporting bias)Unclear riskProtocol not available

Ethical approvalLow riskApproved by the institutional review board

Source of funding or supportLow riskStated (received grants from public institutions)

Conflict of interestUnclear riskSome of the authors had financial and other relationships with some pharmaceutical companies

Chen 2008

Methods2-arm randomised controlled trial, parallel design


Participants29 women with over-active bladder


InterventionsA: Drug alone (n = 14): details of drug including name and dose not stated

B: PFMT + drug (n = 15). PFMT was assisted by perineal surface electromyography and was taught inially. Participants were then instructed to perform 3 sets of PFMT per day, 15 contractions per set, continuously at home for 8 weeks. Drug regimen: as stated above


Outcomes1. Urgency episodes per 24 hours: this was determined at baseline and endpoint using the 3-day voiding diary and mean percentage change was calculated for the 2 groups (no useable data)

2. Daytime frequency per 24 hours: this was obtained before and after treatment using the 3-day voiding diary and mean percentage change calculated (no useable data)

3. Treatment benefit: this was determined 4 weeks post-treatment using the 'Benefit Questionnaire' and proportion of participants with perceived benefits calculated for each group

A: 4/14; B: 11/15

4. Symptom bothersome: scores were obtained before and after treatment and mean percentage change in bothersome scores was obtained for the 2 groups (no useable data)

5. Quality of life: total scores were calculated for different domains of the quality of life (such as sleeping, concern and coping) before and after treatment. Mean percentage increase was calculated for the 2 groups (no useable data)


NotesDropouts: not reported, only the number of participants who completed the trial was stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskProcess involved in randomisation was not reported

Allocation concealment (selection bias)Unclear riskProcess involved in allocation concealment was not stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible (assumed not done)

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot specified

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot reported, only the number of participants who completed the trial was stated

Selective reporting (reporting bias)Unclear riskProtocol not available

Ethical approvalLow riskApproved by the Ethics committee

Source of funding or supportLow riskStated "none" according to the authors

Conflict of interestUnclear riskNot declared

Ghoniem 2005

Methods4-arm randomised controlled trial, parallel design


Participants201 women with predominant symptoms of stress urinary incontinence (SUI)


InterventionsA: No active treatment (n = 47). Received placebo plus imitation (sham) PFMT for 12 weeks. Imitation PFMT consisted of initial therapist-supervised instructions on how to train the hip abductors. Participants were then given written instructions and a training log with the recommendation of 3 sets of 10 long and 2 sets of 10 rapid contractions 4 days weekly. However, no instructions were given to the participants to contract the pelvic floor muscles with physical activities associated with urine leakage (skill training)

B. PFMT only (n = 50). Received placebo plus PFMT for 12 weeks. PFMT comprised 30 minutes of initial therapist supervised instructions on how to contract the pelvic floor muscles. The correct type of contraction was confirmed by pelvic examination. Then participants received instructions to perform 3 sets of 10 long (6 to 8 seconds) and 2 sets of 10 rapid (1 to 2 seconds) contractions 4 days weekly (total of 200 contractions per week). At 4 and 8 weeks, participants received 15 minutes of re-instruction and manual feedback and a training log was completed. Finally, skill training was giving by instructing participants to contract the pelvic floor muscles with physical events usually associated with urine loss

C: Duloxetine + sham PFMT (n = 52). This group received duloxetine and sham PFMT. Duloxetine was given at a dose of 40 mg twice daily for 12 weeks. Sham PFMT (as described above)

D: PFMT + duloxetine (n = 52). This is the combined group. Participants in this group received PFMT and duloxetine as described above

For this review comparison D versus C is relevant


Outcomes1. Incontinence episode frequency (IEF) per week. This was computed from participant completed paper diaries at each visit. Mean (SD) weekly IEF at the endpoint was calculated for each treatment group

A: 18.50 (17.10), n = 44; B: 20.93 (16.26), n = 46; C: 10.96 (8.53), n = 46; D: 11.27 (10.06), n = 44

2. Improvement (IEF responder rate): this was defined as the proportion of participants who had a 50% or greater decrease in IEF with treatment as computed from the paper diaries

A: 11/44; B: 12/46; C: 26/46; D: 27/44

3. Number of continence pads used. Mean (SD) pads per week was calculated for each treatment group at endpoint

A: 10.22 (7.56), n = 44; B: 11.48 (8.36), n = 46; C: 7.23 (5.98), n = 46; D: 7.84 (7.41), n = 44

4. Condition-specific quality of life: this was assessed at endpoint using the Incontinence Quality of Life (I-QoL) score questionnaire and mean (SD) score was obtained for each group

A: 69.34 (20.69), n = 45; B: 68.76 (22.70), n = 49; C: 68.23 (20.87), n = 50; D: 74.07 (19.70), n = 51

5. Patient Global Impression of Improvement (PGI-I): this was defined as the proportion of participants with a PGI-I score in one of the following 3 categories: 1. 'very much better', 2. 'much better' or 3. 'a little better'. This was obtained using the validated PGI-I questionnaire

A: 19/45; B: 32/49; C: 27/50; D: 36/51


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"...treatments were assigned using a centralised computer voice response"

Allocation concealment (selection bias)Low risk"...treatments were assigned using a centralised computer voice response"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDuloxetine and placebo were given in double-blind fashion. However, it is not specified who exactly was blinded. Participants were blinded to PFMT or sham PFMT

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated whether or not outcome assessors were blinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts: all: 56/201; A: 10/47; B: 10/50; C: 19/52; D: 17/52

No differential loss to follow-up between group C and D. However, there is excessive loss to follow-up as 56/201 participants were dropped-out.

Selective reporting (reporting bias)Unclear riskTrial protocol not available

Ethical approvalLow riskApproved by the ethics committee

Source of funding or supportLow riskStated, supported by private organisations

Conflict of interestUnclear riskStated but some of the authors had financial and other relationships with one of the organisations which supported the trial

Hofbauer 1990

Methods4-arm randomised controlled trial, parallel design


Participants43 women with urodynamic evidence of stress urinary incontinence (SUI)


InterventionsA. PFMT + electrical stimulation (ES) (n = 11): participants in this group received both PFMT and ES. PFMT was part of an exercise programme which also included abdominal and hip exercise and was administered twice weekly for 20 minutes by a therapist in addition to a daily home exercise programme. Electrical stimulation consisted of vaginal and lumbar electrodes which were administered for 10 minutes, 3 times weekly for a total of 6 weeks. Output was increased until noticeable contraction was achieved and participant then added voluntary effort

B. PFMT alone (n = 11): as described above

C. Electrical stimulation (ES) alone (n = 11): as described above

D. Sham electrical stimulation (n = 10): as for ES above but current was so low that no effect (contraction) was possible

For this review comparison A versus C is relevant


Outcomes1. Cure: this is the proportion of participants who became continent (free of symptoms of incontinence) at the end of the treatment as reported by the participants

At 10 to 12 weeks from the onset of treatment:

A: 3/11; B: 6/11; C: 1/11; D: 0/11

2. Improvement: proportion of participants who reported improvement in the symptoms of incontinence; success threshold not defined

At 10 to 12 weeks from the onset of treatment:

A: 4/11; B: 1/11; C: 2/11; D: 0/11

3. Success rate: this is the proportion of participants who reported cure of or significant improvement in the symptoms of incontinence

At 10 to 12 weeks from the onset of treatment:

A: 7/11; B:7/11; C: 3/11; D: 0/11


NotesDropouts: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskFurther translation required

Allocation concealment (selection bias)Unclear riskAs stated above

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants undergoing PFMT not possible

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

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts: not reported

Selective reporting (reporting bias)Unclear riskAs stated above

Ethical approvalUnclear riskAs stated above

Source of funding or supportUnclear riskAs stated above

Conflict of interestUnclear riskAs stated above

Ishiko 2000

Methods3-arm randomised controlled trial, parallel design


Participants61 women with symptoms of stress, urinary incontinence


InterventionsA. Drug therapy (DT) group (n = 18). Participants in this group received clenbuterol tablets 20 µg twice daily

B. PFMT group (n = 20). Participants in this group received instructions on PFMT from gynaecologic specialists until they understood the technique. They were then instructed to perform the exercise for 10 minutes daily (other details not reported). Video tapes that demonstrated the proper method of performing PFMT were also given to the participants

C. PFMT + DT group (n = 23): participants in this group received both clenbuterol and PFMT as described above

For this review comparison C versus A is relevant


Outcomes1. Cure: as reported by participants and is the proportion of participants who reported 100% reduction in symptoms of incontinence (i.e. no incontinence at all)

A: 10/13; B: 10/19; C: 17/19

2. Patient satisfaction with treatment outcome: defined as the proportion of participants who were completely satisfied with treatment outcome. Scale used for the assessment not stated

A: 11/13; B: 6/19; C: 13/19


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskThe envelope method was used to randomise participants to treatment groups; not stated whether envelopes were sequentially numbered, opaque and sealed

Allocation concealment (selection bias)Unclear riskThe envelope method was used to randomise participants to treatment groups; not stated whether envelopes were sequentially numbered, opaque and sealed

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants undergoing PFMT not possible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts: all: 10/61; A: 5/18, B: 1/20; C: 4/23

Differential loss to follow-up: not fully reported (2 and 3 participants withdrew from groups A and C respectively due to adverse drug effects; other reasons for withdrawal not reported)

Selective reporting (reporting bias)Unclear riskTrial protocol not available

Ethical approvalLow riskApproved by the ethics committee

Source of funding or supportUnclear riskNot stated

Conflict of interestUnclear riskNot stated

Jeyaseelan 2002

Methods3-arm randomised controlled trial, parallel design


Participants16 women with stress incontinence


InterventionsA. Electrical stimulation (ES) group (n = 6): participants in this group used electrical stimulator for 1 hour a day every day (except when menstruating)

B. Pelvic floor muscle training (PFMT) alone (n = 7): PFMT consisted of individualised exercise regimen with instruction to the participants to carry out a minimum of 3 exercises per day with progression over the treatment period. Biofeedback was provided by means of a Periform probe. Other details not given

C. PFMT + ES (combined) (n = 6). Participants in this group received both PFMT and ES as described above

For this review comparison C versus A is relevant


Outcomes1. Severity of incontinence assessed using 24-hour pad test and 3-day voiding diary

2. Condition-specific quality of life assessed using Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI).


NotesNo useable data were reported in the trial (data reported in median and range)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot reported

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible. Assumed not done

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot explicitly reported

Selective reporting (reporting bias)Unclear riskNot reported

Ethical approvalUnclear riskNot reported

Source of funding or supportUnclear riskNot reported

Conflict of interestUnclear riskNot reported

Jin 2012

Methods3-arm randomised controlled trial, parallel design


Participants242 women with urodynamic evidence of over-active bladder


InterventionsA. Drug alone (n = 82). Participants in this group received oral solifenacin 5 mg once daily  

B. PFMT alone  (n = 80). Participants in this group performed PFMT once daily; other details were not given

C. PFMT + drug (n = 80). Participants in this group received both PFMT and drug as stated above

For this review comparison C versus A is relevant


Outcomes1. Frequency of micturition per 24 hours (no useable data)

2. Number of episodes of over-active bladder in 24 hours (no useable data)

3. Volume of urine voided per micturition in 24 hour (no useable data)

4. Adverse events: proportion (%) of participants who reported adverse events (mainly dry mouth) with solifenacin

A: 17/82; B: 0/80; C: 14/80


NotesDropouts: not reported

All participants randomised at baseline included in analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot reported

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible for PFMT

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

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

Selective reporting (reporting bias)Unclear riskTrial protocol not available

Ethical approvalLow risk"ethics not required" according to the authors

Trial was conducted in accordance with Helsinki declaration

Informed consent was obtained from participants

Source of funding or supportLow riskNo funding source according to the authors

Conflict of interestUnclear riskNot stated

Kim 2011

Methods4-arm randomised controlled trial


Participants147 women with stress, urge or mixed UI from a single centre in Tokyo


InterventionsA. General education (GE) group (n = 36): general education classes were held (topics including cognitive function, osteoporosis and oral hygiene) once a month, a total of 3 times

B. Heat and steam generating sheet (HSGS) group (n = 37): participants in this group received HSGS, a thin, flexible, filmed sheet that generated heat and steam. When placed on the skin surface. It raises the temperature to 38 to 40°C by generating heat and steam continuously for up to 5 hours. Participants were asked to place the HSGS on their lower back once daily immediately after waking period, taking note of the time they started and ended

C. Exercise (Ex) group (n = 37): this group received stretching exercise, fitness exercise and PFM exercise. Participants were initially instructed to perform 10 fast contractions (3 seconds) with a 5-second rest and 10 sustained contractions (8 to 10 seconds) with a 10-second rest between the contractions

D. Ex + HSGS group (n = 37): participants in this group received both exercise and HSGS as described above

For this review comparison D versus B is relevant


OutcomesCure of urine loss episodes (assessed by interview, with cure defined as the proportion of participants with complete cessation of urine loss episodes)

At 3 months:

A: 1/34; B: 8/37; C: 12/35; D: 19/37


NotesChanges in frequency of urine loss episodes: assessed based on changes on a 5-point scale obtained in the interviews conducted at baseline (before treatment) and at 3 months after treatment. Data not available, only graphical presentation  


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskUsed "computer-generated random numbers"

Allocation concealment (selection bias)Unclear riskUsed "computer generated random numbers", however, no further information provided

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of the participants not possible

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

Incomplete outcome data (attrition bias)
All outcomes
Low risk4/147 dropped out of the trial. However, there were no dropouts in the comparison of interest and there was no differential loss to follow-up in the other 1 groups

Selective reporting (reporting bias)Unclear riskProtocol not available

Ethical approvalUnclear riskNot stated

Source of funding or supportUnclear riskNot stated

Conflict of interestLow riskDeclared (no conflict of interest)

Richter 2010

Methods3-arm randomised controlled trial, parallel design


Participants446 women with symptoms of stress urinary incontinence


InterventionsA. Continence pessary alone group (n = 149). Individuals in this group were fitted with a continence ring or dish either by a physician or a nurse. Most participants were fitted successfully in 1 clinic visit while up to 3 visits at 1 to 2-week intervals were allowed for others to achieve optimal fitting. At the end of the 8-week treatment period, participants were encouraged to continue to use the pessary

B. Behavioural therapy (PFMT + continence strategies) (n = 146). Intervention in this group consisted of pelvic floor muscle training (PFMT) and exercise and additional skills and strategies on the use of muscles to prevent urgency and stress incontinence. Treatment was administered by registered nurses, nurse practitioners and physical therapists and was implemented in 4 visits at 2-week intervals. During each visit, participants received instructions on PFMT and exercise and also acquired additional skills and strategies on stress urge incontinence prevention. They were then given individualised prescriptions for daily PFM exercise and practice. At the end of the 8-week treatment period, participants received an individualised home maintenance programme to enable them sustain their skills and muscle strength

C. Continence pessary + behavioural therapy (combined) (n = 150). Treatment regimen was as described for both pessary and behavioural therapy groups. In addition, participants in this group could continue in the trial with only 1 of the therapies at the end of the 8-week treatment period

For this review comparison C versus A is relevant


Outcomes1. The patient global impression of improvement (PGI-I) was assessed for the 3 groups using a validated PGI-I questionnaire with success defined as the proportion of participants with a response of 'much better' or 'very much better'

At 3 months:

A: 59/110; B: 72/124; C: 80/132

At 6 months:

A: 52/102; B: 59/116; C: 63/123

At 12 months:

A: 47/96; B: 48/99; C: 49/111

2. Condition-specific quality of life (in form of the Pelvic Floor Distress inventory): this was assessed using the Urogenital Distress Inventory - stress incontinence sub-scale with success defined as the proportion of participants with absence of bothersome stress incontinence symptoms (indicated by an answer of 'no' to all 6 items on the sub-scale or a response of 'yes' but with a bother of 'not at all' or 'somewhat'

At 3 months:

A: 49/110; B: 71/124; C: 66/132

At 6 months: data not reported

At 12 months:

A: 52/96; B: 59/99; C: 49/111

3. Frequency of incontinence episodes per week (self reported improvement) assessed by using the 7-day diary with success defined as the proportion of women with 75% or more reduction in frequency of incontinence episodes

At 3 months:

A: 69/110; B: 68/124; C: 80/132

At 6 months: data not reported

At 12 months:

A: 51/96; B: 54/99; C: 52/111

4. Patient satisfaction with treatment: this was assessed using the validated Patient Satisfaction Questionnaire

At 3 months:

A: 94/110; B: 110/124; C: 118/132

At 6 months:

A: 87/102; B: 95/116; C: 104/123

At 12 months:

A: 75/96; B: 79/99; C: 81/111


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPermuted block randomisation schedule was used

Allocation concealment (selection bias)Low riskAllocation contained in sealed envelopes, opened by the interventionist only after the participants met all the inclusion/exclusion criteria

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible especially for PFMT

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll outcome assessors were blinded to the treatment group assignment

Incomplete outcome data (attrition bias)
All outcomes
High riskDropouts: at 3 months: all 79/445, C: 18/150, B: 22/146, A: 39/149; at 6 months: all 104/445, C: 27/150, B: 30/146, A: 47/149; at 12 months: all: 139/445; C: 39/150; B: 47/146; A: 53/149

"After randomization, dropout patterns differed among the three treatment groups (P = 0.015) with the pessary only group having the highest attrition rate ..."                                                        

Selective reporting (reporting bias)Unclear riskTrial protocol not available

Ethical approvalLow riskApproved by the ethics committee

Source of funding or supportLow riskDisclosed, funded by "Eunice Kennedy Shriver"

Conflict of interestUnclear riskDeclared some of the authors were associated with a major pharmaceutical company

Wise 1993

Methods3-arm randomised controlled trial, parallel design


Participants62 women with urodynamically proven genuine stress, urinary incontinence (GSI)


InterventionsA. Maximal electrical stimulation alone (n = 20). Participants in this group received a battery-powered vaginal stimulator (impulse frequency: 20 Hz; duration: 0.75 ms; current intensity: 0 to 90 mA) at home daily for 20 minutes

B. Vaginal cones alone (n = 21). Participants in this group were instructed to use cones twice daily for 15 minutes and to increase the weight of the cones when successful on 2 occasions. They did not undergo vaginal examination. It was not reported whether participants were instructed to contract PFMs in order to hold the cones

C. Kegel exercise + vaginal cones (n = 21). Participants in this group received vaginal cones as stated above. In addition, they were taught by vaginal examination to voluntarily contract their pelvic floor muscles and carried out 10 sessions of 10 contractions daily. No further details were reported

For this review comparison C versus B is relevant


Outcomes1. Improvement: threshold not defined, unclear whether self reported, detailed data not reported, only the level of significance was given for each treatment group

2. Reduction in urine leakage: this was assessed objectively (using pad testing); success threshold was not defined, details of data not reported, only P values were given

3. Decrease in pad weight: only the P values were reported, other details not given

4. Improvement on pad testing: objective assessment of improvement using pad testing; only proportions of participants were reported, success threshold was not defined

A: 12/16; B: 14/19; C: 14/15 


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot reported

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible, especially to PFMT

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskDropouts: all 12/62; C: 6/21, B: 2/21; A: 4/20

There is differential loss to follow-up

Selective reporting (reporting bias)Unclear riskTrial protocol not available

Ethical approvalUnclear riskNot stated

Source of funding or supportUnclear riskNot disclosed

Conflict of interestUnclear riskNot disclosed

Wyman 1998

Methods3-arm randomised controlled trial, parallel design


Participants204 women with urodynamic evidence of stress urinary incontinence (GSI), detrusor instability (DI) or both (mixed incontinence).


InterventionsA. Bladder training (BT) group (n = 68): involved a progressive voiding schedule that was altered every week for the first 6 weeks of the programme but remained unchanged for the last 6 weeks. The voiding interval was initially set at 30 or 60 minutes, depending on the baseline voiding diary and increased by 30 minutes each week if there was reduction in episodes of incontinence 

B. Pelvic floor muscle training (PFMT) alone (n = 69). PFMT was also structured and it consisted of an initial teaching session (which also included instructions on continence strategies) followed by a graded home exercise with audio cassette practice tapes and 4 office biofeedback sessions. In all, 10 fast (3-second) contractions and 40 sustained (10-second) contractions (a total of 50 contractions) with 10-second rest periods between contractions were performed daily by the third week. Patients received 4 weekly 30-minute sessions of visual and verbal biofeedback. Visual biofeedback was provided via a strip-chart recorder demonstrating vaginal and abdominal pressures as measured by vaginal balloons

 C. PFMT + BT (combined) (n = 67). Treatment regimen was as described for the BT and PFMT groups. BT was implemented initially while PFMT was added during the third week, including instructions on continence strategies (urge inhibition and preventive contractions)

For this review comparison C versus A is relevant


Outcomes1. Incontinence episodes per week (mean (SD)): this was assessed at endpoint using the records in a standardised diary

Immediately after treatment:

A: 10.6 (16.3), n = 68; B: 9.6 (10.8), n = 64; C: 6.8 (10.7), n = 61

3 months after treatment: data not reported

2. Cure rates: cure was defined as the proportion of participants who had 100% reduction in incontinence episodes, assessed using the standardised diary

Immediately after treatment:

A: 12/67; B: 8/62; C: 19/61

3 months after treatment:

A: 10/63; B: 13/65; C: 16/59

3. Improvement rates: improvement was defined as the proportion of participants who had 50% or greater reduction in incontinence episodes, assessed using the standardised diary

Immediately after treatment:

A: 35/67; B: 36/63; C: 43/61

3 months after treatment:

A: 28/61; B: 36/64; C: 35/59

4. Patient perceived improvement: instrument used in assessment not stated, success threshold was not defined but will be taken as the proportion of participants who were 'much better' or 'somewhat better' for the purpose of this review

Immediately after treatment:

A: 43/66; B: 48/63; C: 55/61

3 months after treatment:

A: 37/60; B: 45/64; C: 44/59

5. Patient satisfaction with treatment outcome: instrument used in assessment not stated, success threshold was not defined but will be taken as the proportion of participants who were 'very satisfied' or 'slightly satisfied' with treatment outcome for the purpose of this review

Immediately after treatment:

A: 48/66; B: 56/63; C: 57/61

3 months after treatment:

A: 47/60; B: 53/64; C: 51/58

6. Condition-specific quality of life assessed at endpoint using:

   i. Urogenital Distress Inventory (UDI); reported as mean (SD):

Immediately after treatment:

A: 95.5 (54.4), n = 67; B: 90.8 (52.0), n = 63; C: 64.4 (48.6), n = 61

3 months after treatment:

A: 91.7 (55.0), n = 60; B: 85.0 (52.4), n = 64; C: 72.8 (50.4), n = 58

   ii. Incontinence Impact Questionnaire-Revised (IIQ-R); reported as mean (SD):

Immediately after treatment:

A: 72.1 (75.2), n = 66; B: 56.8 (61.4), n = 63; C: 46.6 (65.3), n = 61

3 months after treatment:

A: 65.7 (80.2), n = 60; B: 59.3 (67.7), n = 64; C: 59.8 (83.9), n = 58

7. Treatment adherence: this was defined as the proportion of participants adhering to the voiding schedule; assessed using treatment logs or standardised questionnaire (no useable data were: only percentages, without the actual proportions, were reported)

8. Number of women requiring further treatment (relapse): women were followed up for a mean time of 3.2 years and the overall number of women requiring additional treatment such as surgery, drug, etc. was determined for each treatment group

A: 19/48; B: 29/52: C: 18/48


NotesDropouts in each treatment group were not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot reported

Allocation concealment (selection bias)Unclear riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants not possible especially to PFMT

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts: immediately after treatment 9/204; 3 months after treatment 16/204

Differential loss to follow-up: not reported

Selective reporting (reporting bias)High riskOne pre-specified outcome (pad weight) was eventually not reported due to large number of missing data according to the authors

Ethical approvalLow riskApproved by the ethics committee

Source of funding or supportLow riskDisclosed (public institutions)

Conflict of interestUnclear riskNot stated

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Alewijnse 2003Intervention not relevant

Aslan 2008Intervention not relevant

Barber 2008Participants and intervention not relevant

Bawden 1992Intervention not relevant

BE-DRI 2008Intervention not relevant

Berghmans 2000Intervention not relevant

Berghmans 2000aIntervention not relevant

Berghmans 2001aIntervention not relevant

Berghmans 2002Intervention not relevant

Beuttenmuller 2010Intervention not relevant

Bidmead 2002Intervention not relevant

Bo 2002Intervention not relevant

Bo 2012Systematic review

Burgio 1998Intervention not relevant

Burgio 2001aIntervention not relevant

Burgio 2007Intervention not relevant

Cammu 1996Intervention not relevant

Capobianco 2012Participants not relevant

Chancellor 2008Intervention not relevant

Crothers 2003Intervention not relevant

de Jong 2006Intervention not relevant

Dowell 1997Design not relevant

Driusso 2008Intervention not relevant

Dumoulin 2011Intervention not relevant

Fonda 1995Intervention not relevant

Goode 2003Intervention not relevant

Goode 2011aPost-prostatectomy patients

Greer 2012Systematic review

Gunthorpe 1994Intervention not relevant

Ha 2008Intervention not relevant

Hahn 1991Intervention not relevant

Haken 1991Intervention not relevant

Henalla 1989Intervention not relevant

Herschorn 2004Intervention not relevant

Huang 2006Design not relevant

Huang 2012Intervention not relevant

Kafri 2007Intervention not relevant

Kangchai 2002The study is about the efficacy of a self management promotion programme and the participants were not relevant

Kaya 2011Intervention not relevant

Kim 2001Intervention not relevant

Kim 2006Design not relevant

Kim 2007Intervention not relevant

Kim 2009Intervention not relevant

Kincade 2007Intervention not relevant

Kirschner-Hermanns 1995Intervention not relevant

Kobayashi 2009Intervention not relevant

Lagro-Janssen 1991Intervention not relevant

Laycock 1988Intervention not relevant

Laycock 1993Intervention not relevant

Laycock 1995Intervention not relevant

Laycock 2001Intervention not relevant

Lee 2005Intervention not relevant

Madersbacher 2003Intervention not relevant

Madersbacher 2004Intervention not relevant and recruited both men and women with no separate data for women

Maher 2009Intervention not relevant

McCormack 2004Design not relevant

Millard 2003Participants were provided with a leaflet and were not under a structured PFMT programme and included both men and women (no separate data for women)

Millard 2003aParticipants were provided with a leaflet and were not under a structured PFMT programme and included both men and women (no separate data for women)

Millard 2003bParticipants were provided with a leaflet and were not under a structured PFMT programme and included both men and women (no separate data for women)

Millard 2004Participants were provided with a leaflet and were not under a structured PFMT programme and included both men and women (no separate data for women)

Morkved 2002Intervention not relevant

O'Brien 1996Intervention not relevant

Oldham 2010Intervention not relevant

PRIDE 2004Intervention not relevant

Rutledge 2012Intervention not relevant

Sampselle 2003Design not relevant

Sanchez 2008Intervention not relevant

Savage 2005Design not relevant

Scott 1979Randomisation was not done for intervention (incontinence versus no incontinence)

Smith 1994Intervention not relevant

Sran 2011Intervention not relevant

Suzuki 2003Intervention not relevant

Tapp 1987Intervention not relevant

Terry 1996Intervention not relevant

Van Hespen 2006Participants and intervention not relevant

Viereck 2011Intervention not relevant

Voigt 1996Intervention not relevant

von der Heide 2003Intervention not relevant

Waterfield 2007Participant and intervention not relevant

Wells 1999Intervention not relevant

Wilson 1984Intervention not relevant

Yamanishi 2006Intervention not relevant

Yoon 1999Intervention not relevant

Zhao 2000Intervention not relevant

 
Comparison 1. PFMT added to vaginal cones versus vaginal cones alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured or improved (objective assessment)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 3. PFMT added to bladder training versus bladder training alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Immediately after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 3 months after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Number of women cured or improved1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Immediately after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 3 months after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Condition-specific quality of life on IIQ-R1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Immediately after treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 3 months after treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Condition-specific quality of life on UDI1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Immediately after treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 3 months after treatment
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Number of women improved using patient global impression of improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 Immediately after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 3 months after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Incontinence episode per week1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 7 Patient satisfaction with treatment outcome1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 Immediately after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 3 months after treatment
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Number of women requiring further treatment (relapse)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 4. PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Number of women cured or improved1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

 
Comparison 6. PFMT added to continence pessary versus continence pessary alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured or improved1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 At 3 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 At 12 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Condition-specific quality of life on UDI1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 At 3 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 At 12 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Number of women improved using patient global impression of improvement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 At 3 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 At 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.3 At 12 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Patient satisfaction with treatment outcome1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 At 3 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 At 6 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 At 12 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 7. PFMT added to drug therapy versus drug therapy alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 PFMT + clenbuterol vs clenbuterol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Number of women cured or improved1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 PFMT + duloxetine vs duloxetine
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Condition-specific quality of life on I-QoL questionnaire1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 PFMT + duloxetine vs duloxetine
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Number of women improved on patient global impression of improvement in first 3 months2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 PFMT + duloxetine vs duloxetine
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 PFMT + oxybutynin vs oxybutynin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Frequency of incontinence episodes per week in first 3 months2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 PFMT + duloxetine vs duloxetine
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 PFMT + oxybutynin vs oxybutynin
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Frequency of incontinence episodes per week at 12 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 PFMT + oxybutynin vs oxybutynin
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Frequency of micturitions per 24 hours1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 PFMT + oxybutynin vs oxybutynin
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Volumes of urine per micturition1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 PFMT + oxybutynin vs oxybutynin
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Number of continence pads used per week1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    9.1 PFMT + duloxetine vs duloxetine
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 10 Treatment adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    10.1 PFMT + solifenacin vs solifenacin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 11 Patient satisfaction with treatment outcome in first 3 months2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    11.1 PFMT + oxybutynin vs oxybutynin
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    11.2 PFMT + clenbuterol vs clenbuterol
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 12 Treatment benefit1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    12.1 PFMT + ?drug vs ?drug (drug name not reported)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 9. PFMT added to other treatment versus other treatment alone

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of women cured1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 PFMT + heat and steam generating sheet versus heat and steam generating sheet alone
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Summary of findings for the main comparison. PFMT added to vaginal cones versus vaginal cones alone for urinary incontinence in women

PFMT added to vaginal cones versus vaginal cones alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to vaginal cones versus vaginal cones alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to vaginal cones versus vaginal cones alone

Number of women cured or improved (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (pad test)Study populationRR 1.27
(0.94 to 1.71)
34
(1 study)
⊕⊝⊝⊝
very low1,2

737 per 1000936 per 1000
(693 to 1000)

Moderate

737 per 1000936 per 1000
(693 to 1000)

Number of women experiencing pain - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life assessed by patient questionnaire such as Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ) - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Random sequence generation and allocation concealment unclear.
2Confidence interval is very wide (0.94 to 1.71).
 
Summary of findings 2. PFMT added to lifestyle intervention versus lifestyle intervention alone for urinary incontinence in women

PFMT added to lifestyle intervention versus lifestyle intervention alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to lifestyle intervention versus lifestyle intervention alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to lifestyle intervention versus lifestyle intervention alone

Number of women cured or improved (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting adverse events - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 
Summary of findings 3. PFMT added to bladder training versus bladder training alone for urinary incontinence in women

PFMT added to bladder training versus bladder training alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to bladder training versus bladder training alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to bladder training versus bladder training alone

Number of women cured - 3 months after treatmentStudy populationRR 1.71
(0.84 to 3.46)
122
(1 study)
⊕⊝⊝⊝
very low1,2

159 per 1000271 per 1000
(133 to 549)

Moderate

159 per 1000272 per 1000
(134 to 550)

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women experiencing pain - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life - 3 months after treatment
Incontinence Impact Questionnaire- Revised (IIQ-R)
The mean condition-specific quality of life - 3 months after treatment in the intervention groups was
5.9 lower
(35.53 lower to 23.73 higher)
118
(1 study)
⊕⊝⊝⊝
very low1,3

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse)396 per 1000376 per 1000
(226 to 621)
RR 0.95
(0.57 to 1.57)
96
(1 study)
⊕⊝⊝⊝
very low1,4

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Random sequence generation and allocation concealment is unclear.
2Confidence interval is very wide (0.84 to 3.46).
3Confidence interval is very wide (-35.53 to 23.73).
4Confidence interval is very wide (0.57 to 1.57).
 
Summary of findings 4. PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes) for urinary incontinence in women

PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes) for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes)

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to electrical stimulation versus electrical stimulation alone (excluding implanted electrodes)

Number of women curedStudy populationRR 3
(0.37 to 24.58)
22
(1 study)
⊕⊝⊝⊝
very low1,2

91 per 1000273 per 1000
(34 to 1000)

Moderate

91 per 1000273 per 1000
(34 to 1000)

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women experiencing pain - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life assessed by patient questionnaire such as Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ) - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Random sequence generation and allocation concealment unclear.
2Confidence interval very wide (0.37 to 24.58).
 
Summary of findings 5. PFMT added to magnetic stimulation versus magnetic stimulation alone for urinary incontinence in women

PFMT added to magnetic stimulation versus magnetic stimulation alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to magnetic stimulation versus magnetic stimulation alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to magnetic stimulation versus magnetic stimulation alone

Number of women cured or improved (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting adverse events - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life assessed by patient questionnaire such as Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ) - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 
Summary of findings 6. PFMT added to continence pessary versus continence pessary alone for urinary incontinence in women

PFMT added to continence pessary versus continence pessary alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to continence pessary versus continence pessary alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to continence pessary versus continence pessary alone

Number of women cured or improved (subjective) at 12 monthsStudy populationRR 0.88
(0.67 to 1.16)
207
(1 study)
⊕⊕⊕⊝
moderate1

531 per 1000468 per 1000
(356 to 616)

Moderate

579 per 1000510 per 1000
(388 to 672)

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting adverse events - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life at 12 months
Urogenital Distress Inventory (UDI)
Study populationRR 0.81
(0.62 to 1.08)
207
(1 study)
⊕⊕⊕⊝
moderate2

542 per 1000439 per 1000
(336 to 585)

Moderate

494 per 1000400 per 1000
(306 to 534)

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Wide confidence interval (0.67 to 1.16).
2Confidence interval is wide (0.62 to 1.08).
 
Summary of findings 7. PFMT added to drug therapy versus drug therapy alone for urinary incontinence in women

PFMT added to drug therapy versus drug therapy alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to drug therapy versus drug therapy alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to drug therapy versus drug therapy alone

Number of women cured - PFMT + clenbuterol versus clenbuterolStudy populationRR 1.16
(0.83 to 1.63)
32
(1 study)
⊕⊝⊝⊝
very low1,2

769 per 1000892 per 1000
(638 to 1000)

Moderate

769 per 1000892 per 1000
(638 to 1000)

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting adverse events207 per 1000174 per 1000
(1000 to 332)
RR 0.84
(45 to 1.60)
162
(1 study)
⊕⊝⊝⊝
very low1,3

Condition-specific quality of life on I-QoL Questionnaire - PFMT + duloxetine versus duloxetine
Incontinence Quality of Life questionnaire
The mean condition-specific quality of life on I-QoL questionnaire - PFMT + duloxetine versus duloxetine in the intervention groups was
5.84 higher
(2.08 lower to 13.76 higher)
101
(1 study)
⊕⊕⊝⊝
low4

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Random sequence generation and allocation concealment is unclear.
2Confidence interval is very wide (0.83 to 1.63).
3Confidence interval is very wide (0.45 to 1.50).
4Confidence interval is very wide (-2.08 to 13.76).
 
Summary of findings 8. PFMT prior to surgical intervention versus surgical intervention alone for urinary incontinence in women

PFMT prior to surgical intervention versus surgical intervention alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT prior to surgical intervention versus surgical intervention alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT prior to surgical intervention versus surgical intervention alone

Number of women cured or improved (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women reporting adverse events - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life assessed by patient questionnaire such as Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ) - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; PFMT: pelvic floor muscle training

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 
Summary of findings 9. PFMT added to HSGS versus HSGS alone for urinary incontinence in women

PFMT added to HSGS versus HSGS alone for urinary incontinence in women

Patient or population: patients with urinary incontinence in women
Settings:
Intervention: PFMT added to other versus other treatment alone

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlPFMT added to other versus other treatment alone

Number of women curedStudy populationRR 2.38
(1.19 to 4.73)
74
(1 study)
⊕⊕⊕⊝
moderate1

216 per 1000515 per 1000
(257 to 1000)

Moderate

216 per 1000514 per 1000
(257 to 1000)

Number of women reporting incontinence at 1 year or more after treatment (subjective) - not reportedSee commentSee commentNot estimable-Not reported

Objective measure of urine leakage (e.g. pad test) - not reportedSee commentSee commentNot estimable-Not reported

Number of women experiencing pain - not reportedSee commentSee commentNot estimable-Not reported

Condition-specific quality of life assessed by patient questionnaire such as Incontinence Impact Questionnaire (IIQ), King's Health Questionnaire (KHQ) - not reportedSee commentSee commentNot estimable-Not reported

General health status evaluation e.g. Short Form (SF)-36 - not reportedSee commentSee commentNot estimable-Not reported

Number of women requiring further treatment such as surgery, drugs, mechanical devices (relapse) - not reportedSee commentSee commentNot estimable-Not reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; HSGS: heat and steam generating sheet; PFMT: pelvic floor muscle training; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Allocation concealment unclear.