Intervention Review

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Weighted vaginal cones for urinary incontinence

  1. G Peter Herbison1,*,
  2. Nicola Dean2

Editorial Group: Cochrane Incontinence Group

Published Online: 8 JUL 2013

Assessed as up-to-date: 4 MAR 2013

DOI: 10.1002/14651858.CD002114.pub2


How to Cite

Herbison GP, Dean N. Weighted vaginal cones for urinary incontinence. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD002114. DOI: 10.1002/14651858.CD002114.pub2.

Author Information

  1. 1

    Dunedin School of Medicine, University of Otago, Department of Preventive & Social Medicine, Dunedin, New Zealand

  2. 2

    York Hospitals NHS Foundation Trust, Obstetrics & Gynaecology, York, UK

*G Peter Herbison, Department of Preventive & Social Medicine, Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, 9054, New Zealand. peter.herbison@otago.ac.nz.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 8 JUL 2013

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Characteristics of included studies [ordered by study ID]
Arvonen 2001

Methods2-armed RCT. Method of group allocation: not stated. Whether assessor blinded to group allocation: not stated. Duration of treatment was 4 months, final results measured at the end of treatment


Participants40 women with symptoms of stress incontinence, age < 65 y, and an understanding of spoken Swedish. Median (range) age was 49 y (32-64 y) in the vaginal ball group, and 47 y (28-65 y) in the PFMT group. Parity, BMI, duration of symptoms and score on the Sense of Coherence scale were well matched at randomisation


Interventions1. Weighted vaginal balls (n = 20): starting with a ball weighing 65 g, PFMs were squeezed maximally for 20 s, then relaxed for 20 s, with this repeated 10 times. This was done twice daily. In addition, the 50 g ball was retained while moving for 15 min daily. After 2 months the balls were replaced by ones weighing 100 g and 80 g
2. PFMT (n = 20): 10 maximum PFM squeezes while sitting (5-s squeeze, then 5-s break) with a short break after 5 squeezes. Repeated while standing. Whole sequence repeated twice daily. In addition, a 3-s submaximal squeeze followed by a 3-s rest was repeated 15 times once a day


OutcomesShort provocation (60 seconds with standard exercises) pad test with a standard 300 ml in bladder
Vaginal strength measured by digital palpation. Subjective score on a 4-point scale (good/fully recovered, improved, no change, worse)


NotesDropouts: 2/20 in the vaginal balls group, and 1/20 in the PFMT group. Balls made by Vagitrim, Ipex Medical AB, Stockholm, Sweden


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk"The women were randomized into two groups . . ."

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Low riskOutcome reported on all who were randomised

Selective reporting (reporting bias)Low riskNo urinary diaries kept

Other biasLow riskNo reason to suspect this

Arvonen 2002

Methods2-armed parallel RCT. Method of group allocation: not clear. Treatment for 4 months


Participants24 female participants with stress incontinence. Inclusion criteria were leakage of 1-12 g, age 30-65 y and able to understand spoken Swedish. Exclusion criteria were pregnancy, cysto/rectocele, prolapse, ongoing vaginal infection and medication affecting urinary tract function. Women had a mean age of 42 y (range 30-57 y), a mean BMI of 24 (range 19–33), mean number of pregnancies was 2 (range 1–8) and mean duration of symptoms was 6 y (range 1–18 y).


InterventionsThe participants visited the clinics 3 times for assessments and twice for learning the training. All participants were instructed in pelvic floor anatomy and function, and their ability to contract their PFM properly was checked on the first visit. Both groups received verbal information and a written programme from a physiotherapist. The group training with vaginal balls also received a set of vaginal balls

1. PFMT (10 completed the study). 10 contractions 4 times a day performed in both sitting and standing positions. Each contraction supposed to last for 5 s followed by 5 s relaxation. In the second week 15 maximal dynamic contractions of 3-4 s followed by relaxation for 3–4 s and a maximal static contraction for 2 min were added. From the third week the following were also added (all in the supine position with legs bent): contraction-cough 3 times; contraction pelvic lifting 3 times; and contraction sit-up 3 times

2. Vaginal balls (7 completed the study). (Vagitrim, 2 with a diameter of 28 mm weighing 50 g and 65 g, and 2 with a diameter of 32 mm weighing 80 g and 100 g). During the first 2 months the two lighter balls were used for training, and in the following 2 months the heavier two were used. Pelvic floor contraction with the heaviest ball was performed standing, with a foot's-length distance between the feet. A maximal contraction for 20 s held the ball in, followed by 20 s of sitting. This was done 10 times, 4 times a day for a total of 40 contractions. In addition, the lightest ball was used once a day for 30 min while performing activities like walking, doing gymnastics, coughing and lifting


OutcomesProvocation pad test (standard bladder volume of 275 ml followed by standard exercises). Pelvic muscle strength measured by vaginal palpation. Patients subjective assessment on a 4-point ordinal scale, good, improved, no change, worse


NotesPilot study. 2/12 in the PFMT group and 5/12 in the vaginal ball group did not complete the study. Data were reported and medians and range, so not usable apart from the ordinal subjective assessment


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"The patients were consecutively randomised from the physiotherapists' waiting lists to either conventional pelvic floor training or training with vaginal balls by drawing numbered lots."

Allocation concealment (selection bias)Unclear risk"The patients were consecutively randomised from the physiotherapists' waiting lists to either conventional pelvic floor training or training with vaginal balls by drawing numbered lots."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskImpossible to blind participants to treatment group

Blinding (performance bias and detection bias)
Assessor measured outcomes
Low risk"The tests were carried out blind at baseline and after 2 and 4 months."

Incomplete outcome data (attrition bias)
All outcomes
High riskDrop out was differential with more dropping out of the vaginal ball group

Selective reporting (reporting bias)Unclear riskNo urinary diaries kept

Other biasLow riskUnlikely

Bourcier 1994

Methods2-armed RCT. Method of group allocation: not stated. Whether assessor blinded to treatment allocation: not stated. Duration of treatment was 3 months, outcomes were assessed at 6 months from start of treatment. Active period of treatment differed between the 2 arms


Participants102 women with urodynamically proven stress incontinence. Mean age was 38 y


Interventions1. PFMT + cones (n = 50): 3 months of 20 maximal PF contractions 3 times daily, plus use of unspecified cones twice daily and different exercise with instructor for 30 min once a week. After 3 months encouraged to continue the home treatment
2. Electrical stimulation with biofeedback (n = 52): 6 weeks with 2 x 30-min sessions/week: 20 min short-term maximal functional electrical stimulation (parameters unspecified), and 10 min of Electromyography/pressure biofeedback. After 3 months attended clinic weekly


OutcomesContinence status
Unspecified pad test
Urodynamics
PFM strength and endurance


NotesDropouts: 12/50 in PFMT + cones group, and 6/52 in the electrical stimulation + biofeedback group
Only abstract published


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk"We have performed a prospective randomised study . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly completers analysed, moderate withdrawal rate

Selective reporting (reporting bias)Unclear riskUnclear, as only an abstract, no urinary diaries kept

Other biasLow riskNo reason to suspect this

Burton 1993

Methods2-armed RCT. Method of allocation: not stated. Whether assessors blinded: not stated. Duration of treatment not specified, nor the point at which the outcome was measured


Participants61 women with urodynamically proven GSI


Interventions1. Passive cones (n = 31): 15 min twice daily in a static position with unspecified cones
2. Active cones (n = 30): 15 min twice daily while doing standardised activities that previously caused incontinence. Unspecified cones


OutcomesUrodynamics
Cough till leak
40-min pad test
Visual analogue symptom score
Leakage activity index
Psychological adjustment to illness scale


NotesOutcomes reported for all participants
Only abstract published


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk". . . randomised to treatment . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReported that there were no withdrawals

Selective reporting (reporting bias)Unclear riskReported on all outcomes specified, but no urinary diaries kept

Other biasUnclear riskOnly abstract published

Bø 1999

Methods4-armed RCT. Group allocation was blinded. Assessor was blinded to treatment allocation. Assessment was at 6 months from start of treatment


Participants122 women with urodynamically proven GSI. The mean age was 49.5 y (range 24-70 y) and mean duration of symptoms was 10.8 y (range 1-45 y)


Interventions1. Control (n = 32): offered the use of the Continence Guard (Coloplast AS)
2. PFMT (n = 29): 8-12 maximum contractions 3 times daily plus 1 group session/week
3. Electrical stimulation (n = 32): maximum intermittent stimulation with MS106 Twin (Vitacon AS), 50 Hz, pulse width 0.2 ms, current 0-120 mA, 30 min every day
4. Cones (n = 29): 20 min daily. Mabella cones, 3 cylindrical weights: 20 g, 40 g, 70 g


OutcomesStress pad test (30 s running on the spot then 30 s of jumping jacks)
24-hour pad test
3-day leakage episodes
Subjective ratings
Leakage index
Social activity index
Pelvic floor muscle strength


NotesDropouts: 2/32 in controls, 4/29 in PFMT, 7/32 electrical stimulation, and 2/29 in the cones group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomisation schemes stratified by degree of incontinence were constructed for all sites by using computer generated random numbers"

Allocation concealment (selection bias)Low risk"Participants within each stratum were randomised by using opaque sealed envelopes . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReported by group only

Selective reporting (reporting bias)Low riskNo evidence of omitted outcomes

Other biasLow riskNo reason to suspect this

Cammu 1998

Methods2-armed parallel RCT. Method of group allocation: not stated. No attempt at blinding assessment. Duration of treatment: 12 weeks, outcome assessed at end of treatment


Participants60 women with urodynamically proven GSI. PFMT group had a mean age of 55.9 y (SD 9.5), while the cones group had a mean age of 56.3 y (SD 11.4). Duration of symptoms: 6.7 y (SD 7.2) in PFMT group, and 5.3 y (SD 5.2) in cones group


Interventions1. PFMT (n = 30): initial training plus 1 30-min visit/week. 10 fast and 10 slow 10-s contractions for 2 periods of 15 min daily
2. Cones (n = 30): initial training, plus holding cones for 15 min twice daily. Femina cones, 5 conical weights, 20-70 g


OutcomesUrinary diaries (leakages/week)
Pad use
VAS of severity and psychological distress


NotesDropouts: after the first visit 14/30 women in the cones group withdrew, so did not receive the treatment. None of the electrostimulation group withdrew. All participants are in the analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"A list of random numbers were generated using a computer."

Allocation concealment (selection bias)Low risk"A numbered opaque sealed envelope containing the method indicator card was opened by the secretary of the department."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible to blind participants, but possibly influenced by almost half of women in the cones group stopping treatment

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo mention of blinding

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll who were randomised were in the analysis

Selective reporting (reporting bias)Low riskDoes not appear to have any unreported outcomes

Other biasLow riskNo reason to suspect other biases

Castro 2008

Methods4-armed parallel RCT. Method of group allocation not stated. The sole outcome assessor was blinded for outcomes that could be blinded. Treatment was for 6 months with outcomes measured at the end of treatment


Participants118 women with urodynamic stress urinary incontinence and no detrusor overactivity, a positive cough stress test, and > 3 g leakage measured by a pad test with a standardised bladder volume (200 ml). At least 3 stress incontinence episodes/week. Exclusion of women with chronic degenerative diseases, advanced genital prolapse, pregnancy, active or recurrent urinary tract infections, vulvovaginitis, atrophic vaginitis, continence surgery within 1 year and patients with pacemakers. Also excluded were women with intrinsic sphincteric deficiencies defined by the Valsalva leak point pressure of ≤ 60 cm water


InterventionsAll participants were taught to contract the pelvic floor muscles correctly. All active treatments were at a urogynaecology unit 3 times/week under the supervision of a trained physical therapist

1. Pelvic floor muscle training (31 randomised, 26 at assessment). 10 repetitions of 5-s contractions with 5-s recovery, 20 repetitions of 2-s contractions with 2-s recovery, 20 repetitions of 1-s contractions with 1-s recovery, 5 repetitions of 10-s contractions with 10-s recovery followed by 5 repetitions of strong contractions together with a stimulated cough with 1 min interval between sets. General exercises before and after. Exercise in a 45-min group session

2. Electrical stimulation group (30 randomised, 27 at assessment). Cylindrical electrodes, 10 cm long and 3.5 cm wide with a double metal ring. Inserted into the middle third of the vagina. 50 Hz frequency, 5-s on and 10-s off cycle with a pulse width of 0.5 milliseconds. At maximum current intensity tolerated by patient. Each treatment was for 20 min

3. Vaginal cones group (27 randomised, 24 at assessment). 9 cones of equal shape and volume increasing in weight from 20-100 g. Used weight that just required tensing to the pelvic floor to retain, Instructed to leave the cone in for 45 min

4. No treatment group (30 randomised, 24 at assessment). Received a motivational phone call once a month


OutcomesPrimary outcome a negative pad test (< 2 g) with a standardised bladder volume (200 ml). Secondary outcomes were QoL as measured by the I-QoL, number of leakages recorded in the voiding diary, urodynamic testing, and subjective cure (measured as satisfied/dissatisfied)


NotesOnly completers analysed. 17 (14%) withdrew, 5 from the PFMT group, 3 from the ES group, 3 from the cones group, and 6 from the no treatment group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The division of the four groups was undertaken by using computer-generated random numbers prepared by the Biostatistics Center of the Federal University of Sao Paulo"

Allocation concealment (selection bias)Unclear riskThis was not reported

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskThere is uncertainty whether these will be affected by knowledge of the treatment

Blinding (performance bias and detection bias)
Assessor measured outcomes
Low risk"The investigator responsible for assessing patients outcomes was not involved in administering any of the treatments and was blind to the group assignments"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskWithdrawals and dropouts reported by groups and roughly equal, but 17% is more than desirable

Selective reporting (reporting bias)Low riskThere was no obvious failure to report outcomes

Other biasLow riskNo reason to suspect this

Delneri 2000

Methods2-armed parallel RCT. Method of group allocation: not stated. Whether assessors blinded: not stated. Cones treatment lasted 4 weeks; electrical stimulation lasted 16 days. Outcomes assessed at the end of treatment


Participants20 women with urodynamically proven stress incontinence. Cones group mean age 49.5 y, range 29-81 y (SD 14.5). Electrical stimulation group mean age 41.5 y, range 31-54 y (SD 7.4)


Interventions1. Cones (n = 10): held cones for 25-35 min daily for 4 weeks. Femcon cones, 5 conical weights, 20-70 g
2. Functional electrical stimulation (n = 10): 12 consecutive 30-min sessions (excluding Saturday and Sunday). 15 min at 20 Hz and 15 min at 50 Hz. Pulse duration 4 s with 8 s recovery


OutcomesPerineal assessment
Unspecified pad test
Urodynamics
Visual analogue score of overall discomfort caused by incontinence


Notes2 women from the cones group refused follow-up urodynamics


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided. Unclear how the groups were forced to be equally-sized

Allocation concealment (selection bias)Unclear risk"The patients included in the study were randomly divided into two equally-sized groups . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll followed up, except for 2 who refused to be urodynamically tested, but had other outcomes measured

Selective reporting (reporting bias)Unclear riskFollow up pad tests only for those "whose results were positive prior to treatment". No urinary diaries kept

Other biasUnclear riskVery large difference in ages between the two groups (16.5 y reported in the results) but this does not match with the mean ages reported in the methods (49.5 y, SD 14.5, and 41.5 y, SD 7.4) with the cones group being younger

Gameiro 2010

MethodsA prospective single-blind randomised trial. VWC vs APFMT in treatment of urinary incontinence. Participants were systematically allocated into 2 groups, odd numbers into group 1 and even numbers into group 2. Outcomes assessed at 6 and 12 months


Participants103 women referred to the gynaecologist with the predominant symptom of stress urinary incontinence (50% also had urge incontinence). None of the participants had an urodynamic diagnosis of SUI, taken anticholingerics or been treated using pelvic floor exercises or bladder training. The average age in the VWC group was 49 y and 48 y in the APFMT group

Group 1 (n = 51) VWC

Group 2 (n = 52) APFMT


InterventionsThe protocols consisted of 1 40-min session/week over a 12-week period. Patients treated with VWC were assisted by a single physiotherapist, cones varied from 20-70g, and needed to be held in the vagina while walking on the flat, coughing 3 times and then stepping up and down a 2-step stair 10 times. Patients treated with APFMT should perform 2 series of 10 exercises controlled by verbal commands of a single physiotherapist


OutcomesOutcomes assessed at 0, 6 and 12 months

Clinical questionnaire, VAS for assessing the degree of bother in wetness and discomfort, 60-minute pad test, subjective evaluation of PFM using transvaginal digital palpation and objective assessment of PFM using a perineometer


NotesNo dropouts


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk"Patients were systematically allocated, in a single-blind study, into two groups. The odd numbers were included in group 1 (n = 51) and submitted to VWC associated to standardized general exercise; the even numbers were included in group G2 (n = 52) and treated with assisted PFMT." Quasi-random method

Allocation concealment (selection bias)High risk"Patients were systematically allocated, in a single-blind study, into two groups. The odd numbers were included in group 1 (n = 51) and submitted to VWC associated to standardized general exercise; the even numbers were included in group G2 (n = 52) and treated with assisted PFMT." Alternate allocation, so not hidden.

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskStudy says single-blind without saying who was blinded. Main outcomes were participant reports

Blinding (performance bias and detection bias)
Assessor measured outcomes
High riskAlthough study says single-blind it was unclear who was blinded. A single assessor measured all outcomes

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was no loss to follow-up

Selective reporting (reporting bias)Low riskSome outcomes were not fully reported - just stated that there was no statistical significance in the outcome. No urinary diaries kept

Other biasLow riskNo reason to suspect this

Haken 1991

Methods2-armed parallel study. Method of group allocation: not stated. No attempt to blind assessment. All women were taught the appropriate anatomy and physiology. Women seen at 2, 6 and 10 weeks, with outcome assessments at 10 weeks


Participants64 women with urodynamically proven GSI, with a mean age of 48 y


Interventions1. Cones (n = 31): held cone for 15 min twice daily. Femina cones, 5 conical weights, 20-70 g
2. PFMT (n = 33): 5 contractions 10 times daily


OutcomesICS standard 40-min pad test
VAS (details not reported)


NotesDropouts: all women were followed up but 3/33 in the PFMT group, and 8/31 in the cones group withdrew from treatment
Only abstract published


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk". . . were randomised to treatment . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskReported by group, high in the cones group

Selective reporting (reporting bias)Unclear riskNo bladder diary results reported, which is unusual

Other biasLow riskNo reason to suspect this

Harvey 2006

MethodsA single-blinded RCT. Randomised to biofeedback or cones group. Review by research team at 6 months to assess outcomes


ParticipantsAdult clinic patients with symptoms of mainly stress incontinence and confirmed USI on urodynamics. Excluded : > 65 y old, detrusor overactivity, past treatment with cones or biofeedback or electrical stimulation or surgery, pelvic organ prolapse quantification stage > 3

19 women randomised to biofeedback, 25 to cones group


Interventions1. Biofeedback - randomised to biofeedback for 10 weekly sessions with a trained nurse

2. Cones - cones used for 15-20 min daily. If the cone is successfully held for this period for 5 consecutive days then the weight of the cone is increased.


OutcomesOutcomes studied included the presence of USI at 6 months, questionnaires (UDI-6 and I-QoL) and a urine loss on 30-min pad test (with a fixed volume 300 ml)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated

Allocation concealment (selection bias)Low riskSealed opaque envelope

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNot possible to blind treatment provider or participant to treatment

Blinding (performance bias and detection bias)
Assessor measured outcomes
Low riskA single physician blinded to assignment assessed the outcomes

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly 7 participants in each arm returned for end of study urodynamic studies

Selective reporting (reporting bias)Unclear riskNo evidence of unreported outcomes. No urinary diaries kept

Other biasUnclear riskNo reason to suspect this

Laycock 1993

Methods2-armed parallel trial. Method of group allocation: not stated. No attempt at blinding assessment. Women in the electrotherapy (interferential therapy) group agreed not to perform PFMT for the duration of the trial. Treatment for an average of 6 weeks, with assessment within 2 weeks of last treatment


Participants46 women with urodynamically proven GSI, 23 in each arm. Aged from 28-59 y, with mean duration of symptoms of 7 y, with sterile urine


Interventions1. Premodulated interferential (electro) therapy (n = 23): bipolar technique, used an Endomed 433. 1st treatment 15 min, subsequent ones 30 min. 3 different frequencies for 10 min each, 1 Hz, 10-40 Hz, and 40 Hz
2. Cones and PFMT (n = 23): 5 maximum contractions of individualised duration every hour of the day. Cones supplied 2nd visit, used cones for 10 min, 2 times/day. Femina cones, 9 conical weights, 20-100 g


OutcomesStress pad test
Change in digital grading
Subjective assessment
Frequency/volume charts (urinary diaries)


NotesDropouts: none in interferential therapy group, 6/23 in the cones + PFMT group
Many outcomes reported with not enough detail to be included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk"The women were randomised into two groups . . ."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskHigh dropout level in 1 group

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNo reason to suspect this

Laycock 2001

Methods3-armed parallel RCT. Allocation concealment: not stated. Blinding of assessors: not stated. Duration of treatment 3 months, with outcomes assessed at the end of treatment


Participants101 women, in 5 sites, with symptoms of SUI


Interventions1. Cones (n = 41): 10 min daily. Aquaflex cones with unstated number of different weights. 3 months of treatment. Treatment discontinued during menstruation
2. Biofeedback (n = 40): using the PFX (a modified Kegel Perineometer). Individually assessed number of fast and slow contractions, lying and standing for 10 min daily. Increased the number over the 3-month period. Treatment discontinued during menstruation
3. PFMT (n = 20): individually assessed number of fast and slow contractions lying, sitting, and standing for 10 min daily. Treatment continued during menstruation


OutcomesPrimary measures:
Reduction in the frequency of incontinence
VAS of severity
Secondary measures:
Use of pads
Increase in maximum muscle contraction
QoL measured by the King's Health Questionnaire


NotesDropouts: 11/41 in the cones group, 18/40 in the PFX group and 4/20 in the PFMT group
Supported by the makers of the cones and the PFX device


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomization was carried out using prepared random number tables, in the ratio 2:2:1"

Allocation concealment (selection bias)Unclear risk". . . subjects were randomized into three groups . . . "

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskHigh proportion of dropouts

Selective reporting (reporting bias)Unclear riskSeems to have reported all outcomes (without SD). No urinary diaries kept

Other biasUnclear riskNothing obvious

Olah 1990

Methods2-armed parallel design. Method of group allocation: not stated. No attempt at blinding assessment. Assessment was both immediately after treatment, and 6 months from the start of treatment


Participants69 women with symptoms of incontinence, who had not had treatment with PFMT in the last 6 months. Age of the interferential (electrotherapy) group was 47.9 y (SD 13.0), and 43.2 y (SD 8.9) in the cones group


Interventions1. Interferential therapy (n = 36): at a clinic 3 times/week for 4 weeks. Patient semi-recumbent position with 4 vacuum electrodes, 2 on the abdomen and 2 on the inside of the thighs. Frequency 0-100 Hz sweeps, maximum tolerable intensity and each treatment for 15 min. Encouraged to perform PFMT
2. Cones (n = 33): weekly clinic visit for 4 weeks. Held cones for 15 min twice daily. Femina cones, 9 conical weights, 20-100 g. Encouraged to perform PFMT


OutcomesSubjective response
ICS 1-hour pad test
Weight of cone held
Grams of leakage/week assessed through urinary diaries


NotesDropouts: 6/36 in electrostimulation group, 9/23 in cones + PFMT arm. All withdrawals included in analysis. All participants were taught pelvic floor exercises, with no further details about this


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk". . . entered into the trial and randomly allocated . . . " no further information provided

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNot possible to blind, but unlikely to cause bias

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOutcomes reported on all randomised, including those who did not get treatment

Selective reporting (reporting bias)Unclear riskSome results from urinary diary not reported

Other biasLow riskNo reason to suspect this

Peattie 1988a

Methods2-armed parallel RCT. Method of group allocation: not stated. No attempt at blinding assessment. Duration of treatment was 4 weeks, with assessment at the end of treatment


Participants44 premenopausal women with urodynamically proven GSI who were waiting for surgery


Interventions1. PFMT (n = 22): 1-hour initial session, 30-min session a week later, then 15-min 3 weeks later.
2. Cones (n = 22): held cone for 15 min twice daily. Weekly telephone call. Femina cones, 9 conical weights, 20-100 g


OutcomesExtended pad test
Subjective cure
Referral to surgery


NotesDropouts: 5/22 in the cones group, and 6/22 in the PFMT group
Abstract publication was of a continuing trial, with some participants awaiting assessment. More complete information was available from the authors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk". . . women with cystometrically proven genuine stress incontinence were randomly allocated to the use of cones or physiotherapy."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly completers analysed, with approximately 25% withdrawals, some because of lack of compliance

Selective reporting (reporting bias)Unclear riskNo urinary diaries kept

Other biasLow riskNothing suspected

Pereira 2012

Methods3-armed RCT. Method of group allocation: sealed envelopes. Blinding not possible. Outcome measures at end of treatment and 6 weeks post treatment


Participants45 post-menopausal women (no vaginal bleeding for > 12 months), with at least 1 episode of urine leakage during the previous month. Leakage had to be SUI as defined by a positive answer to the Kings Health Questionnaire question "Do you lose urine with physical activities such as coughing, sneezing, running?". Exclusion criteria: previous treatment/surgery for urinary incontinence or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorders, uncontrolled hypertension, and inability to perform the proposed procedures


InterventionsIn the first session women were taught to contract the pelvic floor muscles correctly and they were provided with explanations about the anatomy of the pelvic floor muscles and lower urinary tract, physiology and continence mechanisms

1. Vaginal cones (n = 15). 12 sessions, 2 x 40-min sessions/week. 5 cones used (Femcone) with weighs varying from 20-100 g. A test was performed in each to determine the weight of the cone for proper pelvic floor training. The selected cone was used during all exercises for that session. It is unclear, but it seems that the same exercises were done with the cone inserted as were done in the pelvic floor muscle training group .

2. PFMT (n = 15). 100 contractions/session on average, with some held for 3 s with 6 s of rest, and some held for 5-10 s followed by 10-20 s of rest. Contractions were carried out in the supine, sitting and standing positions. The degree of difficulty progressed with each session

3. Control (n = 15). No treatment during the 6 weeks, but referred for physiotherapy treatment thereafter

At the end of treatment the women in both of the active treatment groups were instructed about the importance of exercises and received a booklet consisting of written instructions and illustrations for continuation of exercises at home twice a week. The vaginal cones group carried out the exercises at home without the vaginal cone


OutcomesPrimary outcomes were 1-h pad weight test and pelvic floor muscle strength measured with a perineometer (Perina Stim). Secondary outcomes were quality of life, satisfaction with treatment and continuity of training


NotesOne published report included information about the 3 month and 12 month follow-up of the active treatment groups. Data were reported as median, minimum and maximum


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe earlier paper stated, "They were allocated according to a computer-generated randomization list into three groups" and the follow-up paper stated, "Participants were randomly assigned following simple randomization procedures". "For the allocation, a researcher not involved in data collection or analysis developed a randomization schedule and produced 45 consecutively numbered, sealed, opaque envelopes containing each participant’s allocation.". Simple randomisation cannot be quite correct as there were exactly 15 in each group, but still low risk

Allocation concealment (selection bias)Low risk"Allocation was concealed in sequentially numbered, sealed, opaque envelopes. Immediately after collecting baseline data, the physical therapist opened the allocation envelope, which contained the participant’s group.". Sealed envelopes should have hidden allocation

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskThese treatments are impossible to blind from the treatment provider and the participant

Blinding (performance bias and detection bias)
Assessor measured outcomes
High risk"Only one unblinded experienced physical therapist performed all evaluations of the three groups."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up at either of the outcome measurements

Selective reporting (reporting bias)Low riskAll likely outcomes measured and reported. Urinary diaries appear to not have been used in this study

Other biasLow riskNothing suspected

Pieber 1995

Methods2-armed parallel RCT. Method of group allocation: not stated. No attempt at blinding assessment. Assessments at 6 and 12 weeks


Participants46 premenopausal women with urodynamically-proven GSI. Mean age was 44.3 y (SD 5.7) in the PFMT group and 41.7 y (SD 6.4) in the PFMT + cones group


Interventions1. PFMT (n = 25): 1 teaching session, then personalised programme. Asked to perform 100 contractions/day, throughout the day. Visit to physiotherapist at intervals of 2-4 weeks
2. PFMT + cones (n = 21): as above, with the addition of holding a cone for 15 min daily. Femcon cones, 5 conical weights, 20-70 g


OutcomesUrodynamic measures
Subjective outcome on an ordinal scale


NotesDropouts: at 6 weeks 9/25 in PFMT, and 8/21 in the PFMT + cones group
1 publication from this study was translated from German


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk". . . according to a random numbers table."

Allocation concealment (selection bias)Unclear riskPatients were randomly assigned to one of the two treatment groups . . ."

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskSome outcomes used last observation carried forward

Selective reporting (reporting bias)Unclear riskDoes not appear to have used, or else not reported urinary diary results

Other biasLow riskUnlikely

Santos 2009

Methods2-armed RCT of 45 patients with SUI. Comparing electrical stimulation of the pelvic floor with cones after 4 months


Participants45 patients with urodynamically confirmed SUI. 24 in the electrical stimulation group and 21 in the cones group.


Interventions1. Electrical stimulation of pelvic floor: participants had 2 x 20-min weekly sessions for 4 consecutive months, under supervision by physiotherapist. Electrode was 10 cm in length and 3.5 cm wide with a double metallic ring and a cylindrical shape, positioned in the middle third of the vagina. Intensity varied from 10-100 mA and 50 Hz with a pulse duration of 1 ms

2. Cones: participants attended 2 x 45-min sessions/week. The cones (Quark brand) varied in weight from 20-100 g


OutcomesAssessment of clinical data: 7-days voiding diary, 1-h pad test and a questionnaire (I-QOL). Measured at baseline and after 4 months


NotesNo participants were lost to follow-up


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"as pacientes foram divididas em dois grupos, de forma randomizada e estratificada, utilizando tábua de números randômicos gerada por computador" translated roughly as "patients were divided into two groups randomly and stratified by using a random number table generated by computer"

Allocation concealment (selection bias)Unclear riskSee above

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskMain outcomes were patient reported and it was impossible to blind them to the treatment

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo mention of who measures the assessor-measured outcomes

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants completed the study

Selective reporting (reporting bias)Low riskNothing is likely to have been omitted

Other biasLow riskNothing likely

Seo 2004

Methods2-armed parallel study. Multicentred, but number of centres not stated. Method of group allocation: not stated. No attempt at blinding outcome assessment. Outcome may have been measured at 6 weeks (unclear)


Participants120 women with SUI (no further details given)


Interventions1. New vaginal cone (n = 60): each cone weighed 150 g; advised to start lying down, and progress to sitting with the cone in place while contracting the pelvic floor. Contract for 5 s, relax for 10 s and repeat for at least 5 min daily for 6 weeks. PFM awareness and compliance were assessed at the hospital once a week
2. FES-biofeedback (n = 60): 2 x 20-min sessions/week of simultaneous electrical stimulation of 35 Hz and 50 Hz


OutcomesImprovement in degree of incontinence
Unspecified pad test
Urodynamics
Vaginal pressure
Duration of PFM contraction
Bladder diary (frequency, leakage episodes)
Difficulty in exercising due to incontinence, social life, daily life, avoiding places, difficulty in personal relationships and QoL scored on a five point Likert scale


NotesNo withdrawals. Badly reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk" . . . divided into two groups". Not enough information provided

Allocation concealment (selection bias)Unclear riskNo information provided

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo clarity about how these were answered

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided about these

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAccording to the report there were no withdrawals

Selective reporting (reporting bias)Low riskSeemed to report all outcomes measured, with nothing missing, but reporting was poor

Other biasLow riskNothing suggestive of this, but poor reporting

Terry 1996

Methods2-armed parallel study. Method of group allocation: not stated. No attempt at blinding assessment. Duration of treatment: 6 weeks; outcome measured at 6 weeks and 6 months after entry


Participants60 women with urodynamically proven SUI, who were able to retain cones


Interventions1. Cones (n = 30): no details of treatment. Used Enhance, 1 cylindrical weight of 75 g
2. Supervised physiotherapy (n = 30): 12 sessions with a combination of interferential therapy and PFMT with no further details provided


OutcomesStress pad test with full bladder
Willingness to continue with treatment (at 6 weeks)
Other outcomes measured but not reported


NotesDroupouts: 19/30 women in PFMT + electrostimulation group, and 7/30 women in the cones group
Only abstract available. Follow-up unclear, but used last result carried forward for those with no measurements


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk". . . randomised in blocks of 20 . . ."

Allocation concealment (selection bias)Unclear risk". . . randomised in blocks of 20 . . ."

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear riskNo information provided

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUsed last observation carried forward, which is not optimal

Selective reporting (reporting bias)Unclear riskUrinary diaries were either not used, or not reported

Other biasLow riskNone suspected

Williams 2006

Methods3-armed parallel study in women after completing an RCT of nurse-led therapy. Allocation clearly concealed, with self-assessment


Participants283 women with urodynamically proven stress or mixed incontinence remaining after an 8-week nurse-led RCT of lifestyle interventions


Interventions3 months of therapy.
1. Pelvic floor muscle training (n = 79): taught to do correct contractions and an individualized exercise programme. Maximum and quick contractions, reinforced at 2-week intervals
2. Vaginal cones (n = 80): Femina cones, 9 weights. Held heaviest cone possible during prescribed exercise, increasing weight when able to hold it for > 15 min
3. Control (n = 79): leaflet about the pelvic floor muscles and 3 steps to exercising them


OutcomesOutcomes measured at 3 months
Primary outcome: frequency of incontinence episodes from 3-day diary
Secondary outcomes: 24-h and 1-h pad tests; participants' perception of severity; assessment of pelvic floor function; voiding frequency; pad usage; blind assessment for urinary dysfunction (Leicester Urinary Symptom Questionnaire); and impact on QoL (Leicester Impact Scale)


NotesDropouts: 7/238; 3 from control group, 3 from PFMT group, and 1 from vaginal cones group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"A statistical programme was used to generate a random allocation sequence . . ."

Allocation concealment (selection bias)Low risk". . . allocation sequence and this was implemented using sealed envelopes numbered sequentially". So this should have hidden the allocation

Blinding (performance bias and detection bias)
Patient reported outcomes
Unclear risk"The patients were interviewed at home by trained interviewers who were independent of the clinical interventions". Urinary diaries were also self-completed

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskUnclear who measured these

Incomplete outcome data (attrition bias)
All outcomes
Low risk"The effectiveness of the interventions was analysed by intention-to-treat." Only a small number with no data

Selective reporting (reporting bias)Low riskAll outcomes reported and nothing obvious missing

Other biasLow riskNothing to suspect

Wilson 1998

Methods2-armed parallel study in women who had incontinence 3 months postpartum. Group allocation: blinded. Blinding of assessors: for some outcomes. Outcomes measured at 12 months postpartum


Participants230 women with symptoms of incontinence 3 months postpartum


Interventions1. No extra intervention (n = 117): told to continue as normal
2. Factorial design, PFMT, cones and both (n = 113):
PFMT (n = 39): 1 training session with physiotherapist plus 3 follow-up visits, fast and slow contractions with aim of 100/day
Cones (n = 36): training session and 3 follow-up visits. Held cone for 2 sessions of 15 min daily. Femina cones, 9 conical weights, 20-100 g.
Both (n = 38): both cones and PFMT


Outcomes'Yes' or 'no' to incontinence, (urinary and faecal)
"Home" pad test
Pelvic floor muscle strength
Teaching time
Sexual satisfaction


NotesDropouts: 26/117 in controls, 59/113 in intervention (20/39 PFMT, 15/36 cones and 24/38 PFMT + cones)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskNot clearly stated, but was computer generated random numbers. "Stratified by parity . . . number of incontinent episodes . . . and type of delivery . . . and was blocked to produce even numbers after every six subjects in each of the strata". "Those in the intervention group were further randomised in a similar manner to subgroups doing PFME only, vaginal cones only, and both PFME and cones."

Allocation concealment (selection bias)Low risk"The assignment was done by means of a computer programme that used files stored in a computer readable form to produce the next assignment."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Low risk". . . recorded by a second physiotherapist, blinded to the group allocation."

Incomplete outcome data (attrition bias)
All outcomes
High riskThere were a large number of dropouts with no outcome data

Selective reporting (reporting bias)Low riskAll outcomes were included and reported

Other biasLow riskNo reason to suspect this

Wise 1993

Methods3-armed parallel study. Method of group allocation: not stated. No mention of blinding of assessment. Duration of treatment: 12 weeks, with women seen at 2, 6 and 12 weeks. Outcome assessment at 12 weeks


Participants61 women with urodynamically proven GSI


Interventions1. Maximal electrical stimulation (n = 20): CONMAX 20 MHz, 0.75 ms pulse duration, continuous stimulation at maximum tolerable intensity between 0 and 90 mA. Home treatment 20 min daily
2. Cones (n = 21): instructed to use cones for 15 min twice daily. Femina cones, 5 conical weights, 20-70 g
3. Cones + PFMT (n = 20): cones as above, with 10 sessions of 10 pelvic floor contractions/day


OutcomesVAS
40-min pad test with standardised bladder volume


NotesDropouts: 4/20 for the electrostimulation group, 2/21 for the cones group, and 6/20 for the cones + PFMT group
Only abstract published


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided

Allocation concealment (selection bias)Unclear risk". . . were randomised to receive treatment with either . . ."

Blinding (performance bias and detection bias)
Patient reported outcomes
High riskNot possible

Blinding (performance bias and detection bias)
Assessor measured outcomes
Unclear riskNo information provided

Incomplete outcome data (attrition bias)
All outcomes
High riskCompleters analysis only

Selective reporting (reporting bias)Unclear riskNo urinary diariesmentioned

Other biasLow riskNo reason for this

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Delgado 2010This was a randomised trial of a resistance training device for women with stress urinary incontinence

Ferreira 2011This was a systematic review of randomised trials, and not a trial itself

Jonasson 1989The women in the study were not incontinent. This study looked at using cones to prevent incontinence

Lentz 1994All women in this study had sensory urgency, so did not fit the inclusion criterion of stress incontinence

Norton 1990Women recruited for this study were not incontinent, but were 6 weeks postpartum. The aim of the study was to look at changes in pelvic-floor strength

Parkkinen 2004This was not a randomised study; women were allocated to groups on the basis of distance from the hospital. Both groups used vaginal balls

Salinas Casado 1999Women recruited for this study were not incontinent. Although the study had a control group, it was not a randomised controlled trial

Williams 2005Nurse-led service that may have used cones, but did not mention this at all

 
Characteristics of ongoing studies [ordered by study ID]
Driusso 2010

Trial name or titlePhysiotherapy for women with stress urinary incontinence: effects of kinesiotherapy, vaginal cones and electrical stimulation

MethodsRCT: "Participants will be divided into four treatment groups"

ParticipantsWomen with urine loss 35 y and over. Exclusion criteria include presence of prolapse greater than grade II, vaginal or urinary infection, uncontrolled hypertension and neurologic or cognitive dysfunction

InterventionsTreatment of individual kinesiotherapy; treatment of group kinesiotherapy; treatment with the use of vaginal cones and treatment with the use of electrical stimulation. The treatment will be 12 sessions lasting 30-60 min and supervised by a physiotherapist. In treatments of kinesiotherapy strengthening the pelvic floor muscles will be accomplished through voluntary contraction in different positions (supine, sitting and standing). In the group treated with vaginal cones, the strengthening will also be accomplished in different positions, but with the introduction of progressively heavier cones. In the group treated with intravaginal electrical stimulation, the electrode is inserted into the vagina of the participant inducing muscle contraction associated with voluntary contraction

OutcomesPrimary outcomes:

Evaluation of the function of the pelvic floor muscles through the digital evaluation of pelvic floor (PERFECT), classified by the Modified Oxford Scale and evaluation of the pressure of contraction of the pelvic floor with use of perineometer Perina (Quark) at baseline and 12 sessions after randomisation, and 6 weeks, 3 months and 1 year after the end of treatment.

Isometric and isokinetic evaluation for the hip adductors and abductors muscle will be assessed using a BIODEX 2 isokinetic dynamometer at baseline and 12 sessions after randomisation.

Urine loss measured by a 1-h pad test and a 3-day voiding diary at baseline and 12 sessions after randomisation, as well as 6 weeks, 3 months and 1 year after the end of treatment.

Secondary outcomes:

Quality of life and sexual function will be assessed through 2 questionnaires: King's Health Questionnaire (KHQ) and Arizona Sexual Experiences Scale (ASEX) at baseline and 12 sessions after randomisation, and at 6 weeks, 3 months and 1 year after the end of treatment

Starting date1 August 2008

Contact informationGrasiela Nascimento Correia, Av. Renato Toledo Porto, 389, Santa Marta. CEP: 13 564-190 Sao Carlos-SP, Brazil. Tel:+55 16 3376 3718, Fax:+55 16 3376 3718, email: grasiela_n_correia@yahoo.com.br

NotesTrial ID: ACTRN12610000254099

 
Comparison 1. CONES versus CONTROL

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

 1 No subjective improvement or cure2215Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.52, 0.99]

    1.1 Urodynamically-proven stress incontinence
2215Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.52, 0.99]

 2 No subjective cure4375Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.76, 0.94]

    2.1 Urodynamically-proven stress incontinence
3263Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.81, 0.98]

    2.2 Symptoms of incontinence
1112Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.40, 1.00]

 3 Leakage episodes per day3261Mean Difference (IV, Fixed, 95% CI)-0.69 [-1.01, -0.38]

    3.1 Urodynamically-proven stress incontinence
3261Mean Difference (IV, Fixed, 95% CI)-0.69 [-1.01, -0.38]

 4 No improvement on pad test4313Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.65, 1.06]

    4.1 Urodynamically-proven stress incontinence
3229Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.66, 1.18]

    4.2 Symptoms of incontinence
184Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.42, 1.12]

 5 Pelvic floor muscle strength4341Mean Difference (IV, Fixed, 95% CI)-1.19 [-3.08, 0.71]

    5.1 Urodynamically-proven stress incontinence
2213Mean Difference (IV, Fixed, 95% CI)0.29 [-1.84, 2.43]

    5.2 Symptoms of incontinence
2128Mean Difference (IV, Fixed, 95% CI)-6.71 [-10.83, -2.59]

 
Comparison 2. CONES versus PELVIC FLOOR MUSCLE TRAINING

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

 1 No subjective improvement or cure6358Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.75, 1.24]

    1.1 Urodynamically-proven stress incontinence
4304Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.75, 1.36]

    1.2 Symptoms of incontinence
254Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.52, 1.29]

 2 No subjective cure5338Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.91, 1.13]

    2.1 Urodynamically-proven stress incontinence
3261Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.94, 1.18]

    2.2 Symptoms of incontinence
277Risk Ratio (M-H, Fixed, 95% CI)0.86 [0.64, 1.14]

 3 Leakage episodes per day4324Mean Difference (IV, Fixed, 95% CI)-7.22 [-0.20, 0.20]

    3.1 Urodynamically-proven stress incontinence
4324Mean Difference (IV, Fixed, 95% CI)-7.22 [-0.20, 0.20]

 4 No improvement on pad test6384Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.76, 1.31]

    4.1 Urodynamically-proven stress incontinence
5314Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.82, 1.49]

    4.2 Symptoms of incontinence
270Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.34, 1.16]

 5 Pelvic floor muscle strength5385Mean Difference (IV, Fixed, 95% CI)-0.61 [-2.49, 1.27]

    5.1 Urodynamically-proven stress incontinence
2214Mean Difference (IV, Fixed, 95% CI)-0.55 [-2.80, 1.71]

    5.2 Symptoms of incontinence
3171Mean Difference (IV, Fixed, 95% CI)-0.76 [-4.17, 2.65]

 
Comparison 3. CONES versus ELECTROSTIMULATION

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

 1 No subjective improvement or cure after treatment3151Risk Ratio (M-H, Fixed, 95% CI)1.26 [0.85, 1.87]

    1.1 Urodynamically-proven stress incontinence
297Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.58, 1.62]

    1.2 Symptoms of incontinence
154Risk Ratio (M-H, Fixed, 95% CI)1.94 [1.02, 3.70]

 2 No subjective improvement or cure after 6 months3154Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.98, 1.59]

    2.1 Urodynamically-proven stress incontinence
2102Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.75, 1.26]

    2.2 Symptoms of incontinence
152Risk Ratio (M-H, Fixed, 95% CI)2.42 [1.33, 4.43]

 3 Leakage episodes per day3157Mean Difference (IV, Fixed, 95% CI)-0.05 [-0.27, 0.17]

    3.1 Urodynamically-proven stress incontinence
3157Mean Difference (IV, Fixed, 95% CI)-0.05 [-0.27, 0.17]

 4 Grams of leakage per day after treatment154Mean Difference (IV, Fixed, 95% CI)0.10 [-0.94, 1.14]

    4.1 Symptoms of incontinence
154Mean Difference (IV, Fixed, 95% CI)0.10 [-0.94, 1.14]

 5 Grams of leakage per day after 6 months154Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.90, 0.50]

    5.1 Symptoms of incontinence
154Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.90, 0.50]

 6 No improvement on pad test after treatment5243Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.90, 1.63]

    6.1 Urodynamically-proven stress incontinence
4189Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.76, 1.46]

    6.2 Symptoms of incontinence
154Risk Ratio (M-H, Fixed, 95% CI)2.14 [1.00, 4.59]

 7 No improvement on pad test at 6 months2105Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.80, 1.89]

    7.1 Urodynamically proven stress incontinence
151Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.62, 1.75]

    7.2 Symptoms of incontinence
154Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.73, 3.34]

 8 Pelvic floor muscle strength161Mean Difference (IV, Fixed, 95% CI)3.50 [-3.32, 10.32]

    8.1 Urodynamically-proven stress incontinence
161Mean Difference (IV, Fixed, 95% CI)3.50 [-3.32, 10.32]

 
Comparison 4. CONES + PELVIC FLOOR MUSCLE TRAINING versus PELVIC FLOOR MUSCLE TRAINING

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

 1 No subjective improvement or cure after 6 weeks146Risk Ratio (M-H, Fixed, 95% CI)1.41 [0.81, 2.45]

    1.1 Urodynamically-proven stress incontinence
146Risk Ratio (M-H, Fixed, 95% CI)1.41 [0.81, 2.45]

 2 No subjective improvement or cure after 12 weeks146Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.51, 1.64]

    2.1 Urodynamically-proven stress incontinence
146Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.51, 1.64]

 3 No subjective cure133Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.63, 2.32]

    3.1 Symptoms of incontinence
133Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.63, 2.32]

 4 No improvement on pad test124Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.45, 1.89]

    4.1 Symptoms of incontinence
124Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.45, 1.89]

 5 Pelvic floor muscle strength132Mean Difference (IV, Fixed, 95% CI)0.60 [-5.58, 6.78]

    5.1 Symptoms of incontinence
132Mean Difference (IV, Fixed, 95% CI)0.60 [-5.58, 6.78]

 
Comparison 5. CONES + PELVIC FLOOR MUSCLE TRAINING versus ELECTROSTIMULATION

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

 1 No subjective improvement or cure after treatment2160Risk Ratio (M-H, Fixed, 95% CI)1.46 [0.82, 2.61]

 2 Changes in leakage episodes per day1120Mean Difference (IV, Fixed, 95% CI)0.42 [0.35, 0.49]

 3 No improvement on pad test281Risk Ratio (M-H, Fixed, 95% CI)0.77 [0.46, 1.30]

 
Comparison 6. CONES versus PELVIC FLOOR MUSCLE TRAINING + CONES

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

 1 No subjective cure135Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.44, 1.58]

    1.1 Symptoms of incontinence
135Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.44, 1.58]

 2 No improvement on pad test269Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.54, 1.68]

    2.1 Urodynamically-proven stress incontinence
142Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.43, 2.35]

    2.2 Symptoms of incontinence
127Risk Ratio (M-H, Fixed, 95% CI)0.90 [0.43, 1.90]

 3 Pelvic floor muscle strength132Mean Difference (IV, Fixed, 95% CI)0.30 [-6.22, 6.82]

    3.1 Symptoms of incontinence
132Mean Difference (IV, Fixed, 95% CI)0.30 [-6.22, 6.82]