Methods

Treatment arms: 2 groups, PFMT and control

Randomisation: a statistician generated and stored the allocation envelopes. Immediately after a woman's initial gynaecologist examination the 1st author gave the next numbered envelope to the woman at the University hospital. The woman opened the opaque sealed envelope herself. Random permuted blocks were not used which resulted in unequal group sizes. There was a significant difference at baseline between the randomised groups in the prevalence of prolapse symptoms (43/59 PFMT group, 26/50 control group).

Stratification: States 2 strata, maximum descent at or above the hymen, below the hymen. However when analyses were reported the number of women was not equal within the "below the hymen" strata: 25 intervention, 15 control. This suggests women were not randomised within strata.

Blinding: the ultrasound films were assessed by an assessor blind to the women's group, clinical and background information. POP‐Q assessment was also blinded in this way. Pelvic floor assessment was not blinded: carried out by the 1st author who was also involved in delivering the intervention.

Power calculation: sample size based on effect size of 0.6 (from study of PFMT for stress urinary incontinence), alpha=0.5, power 80%. Suggested 45 women per group was needed.

Intention to treat analysis: was performed.  Did not perform “per protocol” analysis as there were very few drop‐outs. Baseline values carried forward for 2 women who dropped out.

Follow‐up: women were followed up at 6 months.

Participants

Study population: 109 out of possible 145 women were randomised (36 excluded, 59 PFMT, 50 control). The trial included: women attending for a routine check‐up, women attending with POP symptoms and women interested to know if they might have prolapse.

Number/type of centres: recruitment was by multiple community gynaecologists in Oslo and Akershus.  14 gynaecologists recruited women to the trial. Women were also recruited via newspaper adverts. 

POP‐Qs and ultrasounds were carried out at a University Hospital.  Pelvic floor assessments were carried out at a physical therapy centre by the 1st author.  The intervention was delivered either at a physical therapist centre or at a University Hospital.

Withdrawals: 1 woman in each group withdrew.

Diagnosis: POP‐Q method.

Type of prolapse:

• Anterior prolapse: 54/59 PFMT, 49/50 control

• Posterior prolapse: 46/59 PFMT, 42/50 control

• Apical prolapse: 47/59 PFMT, 41/50 control

Severity of prolapse:

• Stage I: 19/108

• Stage II: 65/108

• Stage III: 24/108

• Not classified: 1

Urinary incontinence present: 51/59 PFMT and 36/50 control women had bladder symptoms at baseline. Urinary incontinence not mentioned specifically.

Inclusion criteria:

• POP‐Q Stage I, II, III

• >= 1 year postpartum

• no prolapse symptoms necessary

Exclusion criteria:

• Cannot contract PFMs

• breastfeeding

• previous POP surgery

• radiating back pain

• pelvic cancer

• neurological condition

• psychiatric disorder

• untreated UTI

• planned pregnancy within 6 months

• planned holiday for > 4 weeks out of the intervention period.

Baseline comparison of treatment groups:

• numbers unequal (59 PFMT vs 50 control) in randomised groups

• significant difference in presence of prolapse symptoms. More PFMT group women had prolapse symptoms (vaginal bulging/pelvic heaviness): 43/59 vs 26/50. i.e. 37% of women were asymptomatic

• no other significant differences.

Characteristics of population:

• Age: 49.4 +/‐ 12.2 PFMT; 48.3 +/‐ 11.4 control

• Parity: 2.4 +/‐ 0.8 PFMT; 2.4 +/‐ 0.7 control

• BMI: 25.8 +/‐ 3.8 PFMT; 26.2 +/‐ 5.33 control

Interventions

Comparisons:

• PFMT vs control

• PFMT pre vs post

• sub‐group analysis of symptomatic women, PFMT versus control

Description:

• Both groups taught the Knack.

• PFMT group: 1 visit per week for 3 months, followed by 1 visit every 2 weeks for 3 months. These were supervised sessions with a physiotherapist. Sessions included 3 sets of 8‐12 maximal contractions in lying, sitting and standing. Daily exercises prescribed 3 sets of 8‐12 close to maximal contractions. Exercise booklet, DVD and diary.

• Control group: told not to start (or stop) PFMT and to avoid straining.

Therapists: 3 women's health physiotherapists (including 1^st author) delivered the intervention.

Compliance:

• 89% of women adhered to home exercise

• 86% of women adhered to physiotherapy sessions.

Outcomes

Definition of cure: Improvement of morphological and functional change. Improvement in symptoms: less frequent symptoms, less bother with symptoms.

Outcomes:

Pre to post change in ultrasound measures (mean change, 95% CI):

intervention control

• Thickness of pubovisceral muscle (mm)             1.4 (0.8, 2.0)       ‐0.5 (‐1.0, 0.0)

• Levator hiatus area at rest (cm²⁾                     ‐1.5 (‐2.4, ‐0.6)        0.3 (‐0.7, 1.2)

• Levator hiatus area at Valsalva (cm²⁾              ‐2.3 (‐4.0, ‐0.5)        0.1 (‐1.7, 1.8)

• Pubovisceral muscle length at rest (mm)         ‐5.1 (‐8.0, ‐2.3)        1.0 (‐2.7, 4.7)

• Pubovisceral muscle length at Valsalva (mm) ‐7.8 (‐13.3, ‐2.3)      3.2 (‐2.2, 8.5)

• Position of bladder at rest in standing (mm)* 4.2 (2.8, 5.6)     ‐0.1 (‐1.9, 1.6)

• Position of rectum at rest in standing (mm)*    3.6 (‐0.3, 7.4)     ‐3.4 (‐6.4, ‐0.3)

*NB. results for bladder and rectum positions differ in the American Journal of Obstetrics and Gynecology paper as different measurement method was used.

POP‐Q:

• % improved 1 stage: 11/58 (19%) PFMT; 4/50 (8%) control (P = 0.035). The authors were contacted and they indicated a Mann‐Whitney U test had been used with the change in POP‐Q stage (1 = improved one stage, 0 = no change, ‐1 = worsening one stage)

• No significant difference between groups in % improved 1 stage for subgroup below the hymen (n = 40, 25 intervention, 15 control): 5/25 vs 3/15.

Improvement in frequency and bother of prolapse symptoms:

vaginal bulging and/or heaviness

• reduced frequency: 32/43 PFMT 8/26 control

• reduced bother: 29/43 PFMT 11/26 control

Improvement in frequency and bother of bladder symptoms (Analysis 1.11):

Percentage with improved frequency and bother of stress and urge symptoms reported. Sample size ranged from 12 to 39 per group as not all women had bladder symptoms to start with. Significant difference in favour of the intervention group for improvement in frequency and bother of stress symptoms, and frequency of urge symptoms.

ICIQ‐UI short form:

Difference between groups 2.40; 95% CI [0.90, 3.80], P = 0.002. It is not clear whether this is based on the change in score. The means for each group are not reported.

Improvement in frequency and bother of bowel symptoms (Analysis 1.21):

Percentage with improved frequency and bother of: difficulty emptying, of flatus leakage, of loose faecal incontinence and of solid faecal incontinence reported. Sample size ranged from 2 to 34 per group as not all women had bowel symptoms to start with. Significant difference in favour of the intervention group for improvement in frequency and bother of flatus, and frequency and bother of loose faecal incontinence.

Pelvic floor muscle assessment (mean change, 95% CI) (Analysis 1.10):

• strength (manometry cmH₂O): 13.1 [10.6, 15.5] PFMT; 1.1 [‐0.4, 2.7] control, P <0.001

• endurance (manometry cmH₂O sec): 107 [77, 136.4] PFMT; 8 [‐7.4, 24.1] control, P <0.001

Notes

• The results from the trial were published in 2 separate papers: ultrasound measure outcomes in one, and symptom and severity in the other. The information on methods and findings have been pooled from these two papers for the purposes of this review.

• Sample size smaller for some outcomes e.g. position of rectum at rest n = 35 vs n = 37.

• Difference between groups in levator hiatus area at Valsalva was reported to be significant but confidence intervals in table 3 contradict this. 

• PFM function is described as an independent variable rather than an outcome measure as the assessor was not blinded to women's group allocation.

• 12/44 postmenopausal women received hormone/oestrogen replacement therapy.

• 10% of control group women reported doing more PFMT than before baseline.

• Data entered into Review Manager for relevant outcomes.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Randomisation: computer generated random number system with concealed envelopes

Allocation concealment (selection bias)

Low risk

Allocation concealment: participants open the envelope.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Blinding: not possible to blind the women. Women were community dwelling therefore no caregiver.  Ultrasounds were taken and assessed blinded to women’s group. Pelvic floor muscle strength (not an outcome measure) assessor not blind to group status as also delivered the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

1 woman in each group dropped out: motivation problems (PFMT woman), offered UI surgery (control woman)

Selective reporting (reporting bias)

Low risk

Other bias

Unclear risk

Not discussed why the numbers are unequal in the randomised groups, and why there are differences in baseline characteristics. May suggest problems with the randomisation process.

Methods

Randomisation: A simple random numbers table was used to generate the sequence. The allocation process was controlled by a researcher not involved in the recruitment, who notified the treating physiotherapist of a woman's group allocation.

Stratification: No stratification was used.

Treatment arms: Comparisons: The trial had 2 arms: 1) physiotherapy‐supervised PFMT intervention (treatment appointment pre‐operatively (n = 1) and post‐operatively (n = 7)) 2) usual care provided by the surgeon.

Blinding: It was not possible to blind patient to group allocation.  The surgeon performing the woman's operation was not blinded.  Assessment of the pelvic floor was undertaken by physiotherapist (first author) blind to the woman's group. Not stated how the assessor remained blinded. The first author also undertook the analysis and was unblinded at that stage. Treatment physiotherapist delivering the intervention was not blinded.

Power calculation: Sample size calculation was based on published prevalence relating to overactive bladder. To detect a 20% difference between groups with 80% power at 5% level of significance, 22 women per group were needed. A target of 58 in total was set to allow for drop‐outs.

Intention to treat: It is stated that an intention to treat analysis was undertaken. However those women who did not receive the allocated intervention and those who discontinued the intervention are not included in analysis (figure 1). Last observation carried forward method was used to handle missing observations.

Follow‐up: Assessment was carried out pre‐operatively and at 3, 6 and 12 months post‐operatively, with 12 months as the primary outcome.

Participants

Study population: Women having vaginal or laparoscopic assisted vaginal surgery for repair of prolapse (primary or recurrent), and/or hysterectomy.

Diagnosis: Women were entered to trial by fact that they were having surgery irrespective of diagnosis.

Number/type of centres: Recruitment took place in 6 metropolitan private hospitals in Melbourne. It was not clear how many gynaecologists were involved in recruiting.

Exclusion criteria: Excluded were women who were having surgery for cancer, or concomitant surgery for urinary incontinence.

Characteristics of population: The type and severity of prolapse were not stated. Not all women had prolapse (3 women had hysterectomy for reasons other than prolapse).

Types of surgery (% in control group/% in PFMT group):

• POP repair with hysterectomy: 56%/50%

• POP repair: 26%/38%

• Hysterectomy for POP: 4%/8%

• Hysterectomy not for POP: 11%/0%

• Conversion to abdominal repair: 4%/4%

Baseline comparison of treatment groups:

• Age: 57.4 (10.3) control; 55.8 (10.7) PFMT

• Weight: 72.7 (12.5) kg control; 68.2 (12.5) kg PFMT

• BMI: 27.6 (4.4) control; 25 (3.5) PFMT

• Vaginal deliveries: 2.4 (1.2) control; 3.2 (1.1) PFMT

Baseline characteristics were similar in each group except the control group had higher BMI (27.6 v 25) and fewer vaginal deliveries (2.4 v 3.2).

Urinary incontinence present: Women self reported the presence of UI: controls were less likely to report incontinence (8/27 control v 18/24 PFMT). Average UDI total score: 41.0 control group and 82.5 treatment group (because of these differences at baseline, time 1 score was used as a covariate in further analyses).

Withdrawals:

• Number who did not receive allocated intervention (withdrew post‐operatively): 1 in the control group, 6 in the PFMT group

• Number who discontinued intervention: 4 in control group (3 had some data for analysis), 3 in PFMT group (2 had some data for analysis)

Interventions

Comparisons: Control (usual care) v Treatment (Physiotherapist supervised PFMT intervention).

Descriptions:

PFMT: 1 pre‐operative appointment and 7 post‐operative appointments. Increase in effort to maximum voluntary contraction, set of 6‐8 second contractions, with rest in between, repeated 8‐12 times, 3 times per day, variety of positions progressing from lying to upright. Early post‐op gradual increase to pre‐op intensity by 6 weeks. Maintenance of intense level for 3‐6 months, then reduction to 1‐2 sets per day by 12 months. At all sessions counterbracing (the Knack) is taught, PFMT is varied according to the individual woman’s needs and adjunctive therapy (biofeedback with pressure manometry, electrical stimulation for absent/very weak contraction or OAB) used at the discretion of the physiotherapist.

All participants: receive usual care from surgeon and nursing staff. In some cases this might include information about pelvic floor exercises and encouragement to perform them, and advice on bladder and bowel function, and general advice on returning to normal activities.

Therapists: No detail was given of the therapists providing the intervention.

Compliance: Adherence with intervention was measured using a training diary in treatment group. There was 89% attendance at physiotherapy appointments, 47% successful receipt of telephone calls, 71% return of home exercise diaries, 89% adherence with the prescribed exercise dose.

Outcomes

Definition of cure: None stated specifically. Sample size calculation suggests a 20% improvement in OAB score from the UDI is considered a clinically reasonable improvement.

Outcomes:

Primary outcome:

•          UDI‐19 (including irritative, stress and obstructive subscales)

•          IIQ‐7

•          3‐day bladder diary

•          48‐hour pad test

Secondary outcome:

•          Modified Wexner Score for faecal incontinence

•          Constipation Scoring System

•          AQoL

•          General exercise participation and perceived level of intensity

•          PFM strength (digital palpation, pressure manometry)

Results:

• There were no significant differences in the change (baseline to 12 month post‐op) in UDI‐19 subscores or IIQ total score between groups.

• There were no significant differences in change scores for bladder diary or pad tests (data not presented in article).

• There were significant differences in change in general exercise frequency and intensity of exercise in favour of the treatment group. There were no significant differences in the other secondary outcome measures.

• Differences between groups were not significant for the bowel or AQoL scores.

• There were no significant differences in the manometry scores between groups.

• Improvement in modified Oxford grade was significantly greater in the intervention group (PFMT: 0.69 SD 0.64 n = 24 vs Control: 0.21 SD 0.66 n = 26, P = 0.01)

Notes

• No note of type of repairs used and no sub‐group analysis of women with POP repair only.

• Time 1 scores included as covariate in analyses to offset baseline differences (e.g. treatment group had higher scores on the three UDI‐19 subscales and the IIQ‐7 at baseline).

• The IIQ‐7 mean change from baseline to 12 months post‐op was summarised as median and 95% confidence interval: control group 0.0 (0, 14), treatment group 10.0 (5, 19)

• 67% of controls stated they performed PFMT throughout the course of the trial.

• Data entered into Review Manager for relevant outcomes.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A simple random numbers table was used to generate the sequence.

Allocation concealment (selection bias)

Low risk

This was controlled by a researcher not involved in the recruitment, who notified the treating physiotherapist of a woman’s group allocation.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Assessment of the pelvic floor was undertaken by physiotherapist blind to group. Not stated how blinding achieved. Treatment physiotherapist not blinded. Not possible to blind patient.  Surgeon not blinded.  Blinding of caregiver not relevant. 

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Withdrawals adequately reported.

Selective reporting (reporting bias)

Low risk

Other bias

Low risk

Methods

Randomisation: No description of the randomisation process. No detail of allocation concealment.

Stratification: No stratification was described

Treatment arms: 2 arms in the trial: conservative treatment group; non‐treated group

Blinding: no detail

Power calculation: no detail

Intention to treat: no detail

Follow‐up: Follow‐up was immediate post‐treatment for the treatment group and 3 months after first consultation for the control group. A 2 year follow‐up was carried out for the treatment group only.

Participants

Study population: Total study population was 47 women; 27 randomised to the treatment group; 20 to the control group

Diagnosis: Diagnosis of prolapse was made using the ICS classification (unsure whether this refers to POP‐Q, the reference given, Cosson et al, could not be obtained). Stage was assessed by gynaecologists.

Number/type of centres: No detail was given about the number or type of centres included in the trial

Inclusion criteria: Women with Stage I or II cystocele, with or without stage I rectocele, were eligible

Exclusion criteria: Advanced prolapse, previous pelvic surgery, having other treatment with potential effect on bladder and sphincter function, neurological condition

Characteristics of population: Average age 53.42 (SD 11.01), duration of symptoms 26.53 months (SD 6.65), pelvic heaviness 85%, dysuria 76.59%, frequency 40.42%, urgency 14.81%, stress incontinence 40.42%

Baseline comparison of treatment groups: Groups were comparable in terms of number of pregnancies, parity and obstetric factors, and chronic bronchitis, constipation and menopausal status

Urinary incontinence present: Urinary incontinence was present in 40.42% of participants

Withdrawals: No detail of withdrawals was given

Interventions

Comparisons: 1) Pelvic floor exercises+healthy living advice vs 2) no treatment.

Descriptions:

PFMT:

• anatomical explanation given and women taught consciousness of PFMs, taught PFEs (stretch reflex technique) + electrical stimulation + digital biofeedback. 24 sessions, 30 minutes per session.

• From 10^th session women practice every day ‐ 20 contractions per day with "self control on the fourchette/perineum". Lifestyle advice give e.g. re heavy lifting, avoiding constipation and chronic cough.

• Compliance checked at each session.

Therapists: No detail of who delivered the intervention, nor the total duration.

Compliance:

Outcomes

Definition of cure: Definition of cure appears to be absence of pelvic heaviness.

Outcomes:

• Report of pelvic heaviness: 5/27 intervention; 14/20 control

• Clinical exam to assess severity: not reported

• Prevalence of urinary symptoms:

  • dysuria (pain): 5/27 intervention; 12/20 control

  • urgency: 1/27 intervention; 7/20 control

  • stress incontinence: 2/27 intervention; 7/20 control

  • frequency: 4/27 intervention; 11/20 control

• Measurement of urinary handicap (MUH) scale

  • total score: 6.48 (2.63) intervention; 15.7 (2.43) control

  • urge subscore: 2.18 (1.38) intervention; 5.25 (1.91) control

  • stress UI subscore: 1.88 (1.47) intervention; 3.45 (1.31) control

  • frequency subscore: 1.77 (1.25) intervention; 5.2 (1.67) control

  • dysuria subscore: 0.59 (0.57) intervention; 1.8 (0.95) control

• Levator ani strength: 2.37 (0.83) intervention; 1.25 (0.78) control

• Urodynamic tests:

  • closure pressure: 57.81 (12.8) intervention; 52.95 (12.18) control

  • flow: 16.33 (2.51) intervention; 13.1 (3.83) control

  • post‐void residual: 57.81 (12.8) intervention; 79.09 (23.75) control

• Ditrovie QoL scale: 2.07 (0.57) intervention; 2.57 (0.43) control

• Patient satisfaction on VAS (have you felt an improvement and how do you rate it?): 6.77 (1.12) intervention; 3.55 (0.88) control

Immediately post‐treatment, pelvic heaviness persisted in five women (19%) from the treatment group compared with fourteen (70%) in the control group (P < 0.001). There were also significant differences in other outcomes, including quality of life and urodynamic measures. It was reported that 20 women from the intervention group retained benefits two years after the treatment had ceased.

Notes

• Article in French (trial took place in Tunisia) with English abstract. Two partial translations obtained. Authors emailed but no reply received.

• The sample size is not given for each of the outcomes reported, and there is no information about withdrawals or the numbers available for treatment. It is assumed in this review for the purposes of data analysis that the treatment group sample size is 27, and the control group sample size is 20 throughout.

• The Ditrovie scale measures QoL associated with urinary symptoms. The authors may have altered the scale to assess QoL associate with prolapse.

• 20/27 in the treatment group attended and were reviewed 2 years after they stopped the intervention. Data are presented on symptoms, flow, QoL and satisfaction.

• Compliance was graded “good” if woman complete 20 contractions every day, medium if she completed 3 times a week, bad if she completed 0 or 1 times a week.

• Data entered into Review Manager for relevant outcomes.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

no description given

Allocation concealment (selection bias)

Unclear risk

no description given

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

no description given

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

no description given

Selective reporting (reporting bias)

Unclear risk

no description given

Other bias

Unclear risk

no description given

Methods

Randomisation: Randomised controlled trial, single blind. Automated telephone randomisation system for group allocation.

Stratification: Stratified by number of deliveries and centre.

Treatment arms: PFMT versus control (lifestyle leaflet)

Blinding: Women and therapist not blind to group allocation. Gynaecologist undertaking POP‐Q assessment blind to group allocation (women asked not to reveal their group and chaperone at assessment to enforce this).

Power calculation: feasibility study therefore no power calculation carried out.

Intention to treat: women analysed in the group they were randomised to.

Follow‐up: questionnaire follow‐up at 20 weeks and 26 weeks post‐randomisation; gynaecology review appointment (including POP‐Q) at 20 weeks post‐randomisation.

Participants

Study population: 47 women with stage I or II prolapse of any type identified at their first appointment at gynaecology outpatient clinics at two centres in Scotland; 23 intervention, 24 control.

Diagnosis: prolapse of any type diagnosed using the POP‐Q assessment carried out by a gynaecologist at the first appointment.

Number/type of centres: 2 centres, both large teaching hospitals

Exclusion criteria: stage 0, III or IV prolapse; main presenting problem not prolapse

Characteristics of population:

• Age: mean 56 years (SD 9)

• Vaginal deliveries: all women had had at least 1 vaginal delivery and 40% (the largest group) had had 2 vaginal deliveries; 45% reported at least 1 forceps delivery; no caesarean sections were reported.

Baseline comparison of treatment groups: There were no significant differences between the groups with respect to age, parity, method of delivery, type or duration of prolapse, or prevalence of symptoms.

Withdrawals: intervention group 4, control group 3; questionnaire response rate at 20 weeks was 87% and at 26 weeks was 85%; 89% of women attended their 20‐week follow‐up gynaecology review appointment when POP‐Q reassessment was undertaken.

Interventions

Comparisons: PFMT group versus control group.

Descriptions:

PFMT: Women in the intervention group attended 5 physiotherapy sessions over 16 weeks (weeks 0, 2, 6, 11 and 16) where pelvic floor exercise techniques were taught and advice on modifying lifestyle was given. An individually tailored exercise programme was provided by the physiotherapist which was performed by the women at home. 6 sets of exercises per day was recommended. One set consisted of up to 10 maximum voluntary contractions held for up to 10 seconds, with 4 seconds rest between each contraction and, after a 1 minute rest, 10 or more fast contractions in a row.

Control: The control group were sent a lifestyle advice leaflet containing things they might try to help prolapse (weight loss, and avoidance of constipation, heavy lifting, coughing and high impact exercise).

All participants: Both groups of women had a review appointment with a gynaecologist at 20 weeks post‐randomisation.

Therapists: local physiotherapists, who were specialists in women's health, delivered the PFMT intervention. There were 2 intervention physiotherapists at each centre.

Compliance: 91% of intervention women attended 3 or more PFMT appointments, 74% attended 4 appointments, and 65% attended 5 appointments. 61% of women in the intervention group were rated as good or moderate exercise compliers.

Outcomes

Definition of cure: improved prolapse symptoms.

Outcomes: outcomes measured were POP‐Q (baseline and 20 weeks), symptom and quality of life questionnaires relating to prolapse, urinary symptoms, bowel symptoms and sexual function (baseline, 20 and 26 weeks), general health status.

Primary outcome: prolapse symptom severity measured using the Prolapse Symptom Score (POP‐SS) and prolapse related quality of life (visual analogue scale).

Secondary outcome: prolapse severity (POP‐Q), urinary leakage (ICIQ‐UI SF), bowel symptoms (ICIQ bowel), sexual symptoms (ICIQ vaginal symptoms), general health status (SF‐12).

Results:

• Prolapse symptom score: mean change score from baseline to 2 weeks ‐3.5 (SD 5.4) intervention (n = 17), mean change score ‐0.1 (SD 2.9) control (n = 20); 95% CI for difference in change score between groups [0.53, 6.21].

• Prolapse QoL score: mean score 2.0 (SD 1.5) intervention, mean score 2.1 (SD 2.3) control (mean difference ‐0.10 95% CI [‐1.29, 1.09]).

• Change in POP‐Q severity by 20 weeks: no change or worse stage 6/11 intervention, 9/9 control (RR 0.55 CI [0.32, 0.94]).

• Change (cm) in POP‐Q measurement by 20 weeks: mean change in Aa ‐0.36 (SD 1.86) intervention, 0.67 (SD 0.71) control (mean difference ‐1.03 CI [‐2.22, 0.16]); mean change in Ba ‐1.09 (SD 1.22) intervention, 0.56 (SD 1.01) control (mean difference ‐1.65 CI [‐2.63, ‐0.67]). No significant differences were found for other POP‐Q points.

• Self‐reported change in prolapse at 26 weeks: number same or worse 7/19 intervention, 16/21 control (RR 0.48 CI [0.26, 0.91]).

Notes

• This trial was a feasibility study intended to test the methods for a larger multi‐centre trial.

• Pelvic floor muscle strength, measured using the modified Oxford scale in the intervention group women only, increased significantly (mean increase 0.5, SD 0.6, t = ‐3.09, df 14, P = 0.008, 95% CI [0.2, 0.8]).

• Data entered into Review Manager for relevant outcomes.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

computer generated allocations

Allocation concealment (selection bias)

Low risk

remote system with telephone access

Blinding (performance bias and detection bias)
All outcomes

Low risk

not possible for questionnaires, attempted for POP‐Q assessment (achieved in 37 out of 42 follow‐up POP‐Q assessments)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Other bias

Low risk

Methods

Randomisation: randomised controlled, single blind trial. Randomisation in blocks of size 20. Allocation by computer‐generated random numbers. Information on group allocation was stored in a separate location, concealed in opaque envelopes. The treating physiotherapist opened the envelope after a woman was recruited.

Stratification: none mentioned

Treatment arms: PFMT versus standard care

Blinding: pelvic floor muscle assessment and paper towel test at 12 weeks were blinded.

Power calculation: used a clinically significant difference between the groups of 30% from other quality of life studies. Based on this assumption, a sample size of 60 was required with 30 in each group.

Intention to treat: not mentioned. No details of numbers in the analysis in order to judge.

Follow‐up: Women were followed up for 3 months.

Participants

Study population: 60 women who were scheduled to undergo surgery to correct prolapse and/or incontinence. 30 intervention, 30 control. Recruitment April 2000 to December 2003.

Diagnosis: prolapse and/or urinary incontinence.

Number/type of centres: endo‐gynaecology department at 1 hospital. Recruitment involved women having surgery with 23 gynaecologists at the hospital.

Exclusion criteria: women with neuromuscular disorders or other significant medical problems, or those who had pelvic floor muscle intervention as a routine part of their presurgical assessment. Women undergoing tension‐free vaginal tape as the sole intervention were also excluded due to short length of their hospital stay.

Characteristics of population:

Baseline comparison of treatment groups:

Demographics and type of surgery for the two groups were similar. There were
no differences in the type of surgery undertaken between the groups.

• Age: intervention mean 62.6 (SD 10.5) range [40‐76], control mean 62.8 (SD 11.1) range [47‐78]

• Weight ‐ not reported

• Bmi: intervention mean 27, range 20–40, SD 4.2; control mean 27.4, range 21–32, SD 2.8

• Parity: intervention mean 2.5, range 0–5, SD 1.1; control mean 2.6, range 1–7, SD 1.2

• type of surgery: prolapse surgery alone 17/30 intervention group, 23/30 control group

Urinary incontinence present: not known as baseline urinary measures not presented.

Withdrawals: Surgery was cancelled for 3/30 intervention women and 1/30 control woman. States 4 intervention women and 2 control women dropped out. Authors state there were a number of missed appointments and women lost to follow‐up, but the details are not given. It is not known how many women are therefore included in the data analysis.

Interventions

Comparisons: PFMT versus control.

Descriptions:

PFMT: Instructions were given by a physiotherapist on the performance of pelvic floor muscle exercises, and an individually tailored programme of pelvic floor muscle exercises was provided. Women were advised to do 4 sets of exercises a day. Information and advice on pelvic bracing, voiding postures and defaecation techniques. Intervention women saw the physiotherapist on the second post‐operative day to reinforce the exercise program, and had a 6‐week post‐operative visit.

Control: Received standard care. Did not receive the PFMT intervention.

All participants: Women in both the intervention and control group underwent surgical procedures for prolapse and/or incontinence and received standard care.

Therapists: no detail

Compliance: not reported

Outcomes

Definition of cure:

Outcomes:

No prolapse‐specific outcomes were measured. At baseline (pre‐admission) and 12 weeks post‐operatively all women had:

• pelvic floor muscle assessment (Oxford scale and manometry)

• paper towel test,

• standardised urinary symptom‐specific health and quality of life questionnaire (Kelleher 1997) 48‐hour urinary frequency/volume diary

Primary outcome: no primary outcome specified although sample size based on difference in quality of life.

Secondary outcome: not specified

Results:

• There was a significant improvement in urine leakage for the intervention (mean reduction 62 cm³) and control group (mean reduction 32cm³), but there was no significant difference in improvement between the groups (95% CI ‐11.4 to 72.3 cm³; P = 0.150).

• Both groups had an improvement in urinary symptoms but the improvement for the intervention group (mean reduction 6.3) was significantly greater than for the control group (mean reduction 2.4) (between group difference in mean reduction 3.8; P = 0.017; 95% CI 0.7 to 6.9).

• Reduction in diurnal frequency was significantly greater in the intervention group (mean reduction 1.5) than in the control group (mean reduction 0.4) (P = 0.024).

• Improvement in mean maximum squeeze was significantly greater in the intervention group (mean change 2.7 cm H₂O) than the control group (mean change ‐1.8 cm H₂O). The difference in mean maximum squeeze pressure between groups was reported to be significant: P = 0.022; 95% CI ‐9.92 to ‐0.81.

Notes

• 2 women in the trial were to have incontinence surgery without concurrent prolapse surgery, both were in the intervention group. No subgroup analysis of those women who only had prolapse surgery.

• the authors did not report the number of women in each analysis or the standard deviations, thus the data were not entered in this review.

• unclear when the baseline assessments took place. Women were approached about the trial 2‐4 weeks before surgery at a pre‐admissions clinic. Not clear if they were consented, randomised and baseline measures taken at this point also.

• Data not entered into Review Manager as no standard deviations or numbers (n) reported, only mean values for each group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

opaque envelopes stored in a location away from the clinic

Blinding (performance bias and detection bias)
All outcomes

Low risk

physiotherapist undertaking the 12 week assessments was blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

details of missing data, other that number of women who withdrew, not given

Selective reporting (reporting bias)

Low risk

Other bias

Unclear risk

not clear what the sample sizes were for the outcomes reported as no details of missing values given

Methods

Randomisation: Cluster randomised controlled, single blind trial. No detail of randomisation method. Clustering by post code area.

Stratification: none mentioned

Treatment arms: pelvic floor muscle training versus non treated control

Blinding: doctor assessing prolapse at follow‐up was blinded to the woman's previous assessment. No mention of blinding of group allocation.

Power calculation: no power calculation was described

Intention to treat: no mention of whether an intention to treat analysis was used

Follow‐up: Follow‐up was conducted at 6, 12 and 24 months. 18‐month follow‐up planned but was not possible.

Participants

Study population: 654 community‐dwelling Thai women, over 60 years of age and living within 10 km of the hospital where the trial was conducted, with or without anterior wall pelvic organ prolapse. Intervention: n = 330, control: n = 324.

Diagnosis: vaginal examination before and during Valsalva. No prolapse: anterior wall did not protrude during Valsalva; mild prolapse: protrusion of anterior wall during Valsalva which could be measured by area; severe prolapse: protrusion of anterior vaginal wall during Valsalva which could be by volume.

Number/type of centres: women were recruited via 1 hospital

Exclusion criteria:

• chronic cough

• needing gynaecological surgery

• using HRT

• previous A‐P repair or conization

• abnormal smear

• difficulty communicating

Characteristics of population: 69.9% of the 682 women examined had anterior prolapse, of whom 30.4% had severe prolapse and 39.6% had mild prolapse. 654/682 women were eligible for the trial. Age range 60 to 88 years, 50% age 60 to 65 years, 25% 66 to 70 years, 25% >70 years. The largest group, 41.6%, had had between 4 and 6 births.

Baseline comparison of treatment groups:

There were no significant differences between groups in the baseline characteristics.

• Age, mean (SD): 67.0 (5.6) intervention group, 67.7 (5.7) control group

• Age at menarche, mean (SD): 15.7 (1.9) intervention, 15.8 (2.0) control

• Age at menopause, mean (SD): 48.5 (4.5) intervention, 47.8 (4.7) control:

• Total number of deliveries: 1631 intervention group, 1598 control group

• Total number of caesarean sections: 15 intervention, 10 control

Urinary incontinence present: no detail given

Withdrawals: based on information about attendance at follow‐up appointments it appears that 88 intervention group women and 91 control group women did not attend for any follow‐up.

Interventions

Comparisons: PFMT versus control

Descriptions:

PFMT: instruction in the performance of pelvic floor muscle exercises. It appears that this happened on one occasion but if a woman could not perform them correctly, she attended monthly until she could do so. 30 exercises "after one meal every day" (note: personal communication with the lead author suggested it was exercise after EACH meal). In addition, advice on diet regarding alleviating constipation (to eat more fruit, vegetables and boiled rice, and to drink at least 2 litres of water a day).

Control: no treatment.

Therapists: No indication of who delivered the intervention.

Compliance: All the women were eventually able to perform the exercises satisfactorily. No details of compliance.

Outcomes

Definition of cure: The success of the intervention in preventing the worsening of anterior wall prolapse was assessed.

Outcomes:

Primary outcome: The main outcome recorded was the severity of prolapse, assessed using a study‐defined (i.e. non‐standardised) system: on Valsalva, no prolapse (no protrusion of the anterior vaginal wall), mild (protrusion of anterior wall seen and measured as an area) or severe (protrusion measured as a volume).

• It was reported that at a 6 month follow‐up, there were no significant differences in the number of women with worse prolapse between the treatment and control groups, either for women classified initially with mild or severe prolapse.

• For women with mild prolapse at the outset, those in the intervention group were reported to be significantly less likely to have worse prolapse at 12 month follow‐up than those in the control group. By the 24 month follow‐up, however this difference between the groups was no longer evident.

• For women initially classified with severe prolapse, there was no difference between the treatment and control groups at the 12 month follow‐up. However, women in the intervention group were less likely to have worse prolapse at 24 month follow‐up (28%) than those in the control group (72%) (P < 0.05). These two percentages were the only outcome data reported. It is not clear whether or not clustering was allowed for in the analysis.

Secondary outcome: There were no outcome measures relating to symptoms of prolapse or to constipation, other bowel or urinary symptoms. It was reported however that some women did not need to use laxatives.

Notes

• Initially 682 women were examined for prolapse: 477 were found to have either "mild" or "severe" prolapse and 205 had no prolapse. 654 of the 682 women were eligible for the trial thus implying that some women with no prolapse were included. However trial results were only presented for women who originally had mild and severe prolapse.

• The actual numbers of women who became worse, and the numbers of women assessed at each follow up were not always presented. Requests for additional data with more detailed breakdown were unsuccessful.

• It is not clear who delivered the intervention, only that women attended a clinic.

• The duration of hold of the pelvic floor muscle contractions was not reported.

• No data entered into Review Manager due to insufficient reporting.

• The lead author was contacted by letter and then telephone and some clarification regarding methods was obtained, although language was a barrier to communications. It was agreed with the author that a further request for greater detail regarding the results was to be faxed. A response to this request was not received.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No detail of randomisation process.

Allocation concealment (selection bias)

Unclear risk

No detail of allocation process.

Blinding (performance bias and detection bias)
All outcomes

High risk

Doctor assessing prolapse at follow‐up was blinded to the woman's previous assessment, but no mention of whether blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No information given about attrition.

Selective reporting (reporting bias)

High risk

Seems that data only reported for a subgroup of the women randomise: those with mild or severe prolapse at the start, excluding those with no prolapse. Numerical information presented was limited.

Other bias

Unclear risk

no description given