Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial.

BACKGROUND: Antenatal pelvic floor muscle exercises (PFME) in women without prior urinary incontinence (UI) are effective in reducing postnatal UI; however, UK midwives often do not provide advice and information to women on undertaking PFME, with evidence that among women who do receive advice, many do not perform PFME. METHODS: The primary aim of this feasibility and pilot cluster randomised controlled trial is to provide a potential assessment of the feasibility of undertaking a future definitive trial of a midwifery-led antenatal intervention to support women to perform PFME in pregnancy and reduce UI postnatally. Community midwifery teams in participating NHS sites comprise trial clusters (n = 17). Midwives in teams randomised to the intervention will be trained on how to teach PFME to women and how to support them in undertaking PFME in pregnancy. Women whose community midwifery teams are allocated to control will receive standard antenatal care only. All pregnant women who give birth over a pre-selected sample month who receive antenatal care from participating community midwifery teams (clusters) will be sent a questionnaire at 10-12 weeks postpartum (around 1400-1500 women). Process evaluation data will include interviews with midwives to assess if the intervention could be implemented as planned. Interviews with women in both trial arms will explore their experiences of support from midwives to perform PFME during pregnancy. Data will be stored securely at the Universities of Birmingham and Exeter. Results will be disseminated through publications aimed at maternity service users, clinicians, and academics and inform a potential definitive trial of effectiveness. The West Midlands-Edgbaston Research Ethics Committee approved the study protocol. DISCUSSION: Trial outcomes will determine if criteria to progress to a definitive cluster trial are met. These include women's questionnaire return rates, prevalence of UI, and other health outcomes as reported by women at 10-12 weeks postpartum. Progress to a definitive trial however is likely to be prevented in the UK context by new perinatal pelvic health service, although this may be possible elsewhere. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN10833250 . Registered 09/03/2020.

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review.

Pelvic floor muscle training (PFMT) is a first-line therapy for women with stress, urgency or mixed urinary incontinence (UI). Supervision and content of PFMT programmes is highly variable. The most effective approach to training is not known. The aim of the review was to compare the effects of different approaches to PFMT for women with UI. This was a systematic review with meta-analysis of randomized or quasi-randomized trials in women with stress, urgency or mixed UI that compared one approach to PFMT with another. The Cochrane Incontinence Group Specialised Trials Register (17 May 2011) was searched. Two reviewers independently assessed trials for eligibility and risk of bias, and extracted data. Data were analyzed as described in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.2.2). From 574 records we included 21 trials (1490 women randomized) that addressed 11 comparisons. Comparisons made included: differences in training supervision (amount, individual versus group), in approach (one versus another, the effect of an additional component) and the exercise training (type of contraction, frequency of training). There were few trials or data in any comparison. In women with stress UI, 10% who received more health professional contact (weekly or twice-weekly group supervision plus individual appointments) did not report improvement compared to 43% who had individual appointments only (risk ratio for no improvement 0.29, 95% confidence interval 0.15 to 0.55, four trials). While women receiving more contact were more likely to report improvement, the confidence interval was wide, and more than half of "controls" reported improvement. This finding, of subjective improvement in both active treatment groups, with more improvement reported by those receiving more health professional contact, was consistent throughout the review. Considerable caution is needed in interpreting the results of the review. Existing evidence is insufficient to make any strong recommendations about the best approach to PFMT. A consistent pattern of more self-reported improvement with more health professional contact was observed; the few data consistently showed that women receiving regular (e.g. weekly) supervision were more likely to report improvement than women doing PFMT with little or no supervision. The clinical rehabilitation impact is to offer women reasonably frequent health professional contact during supervised PFMT.

Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling. DATA SOURCES: The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database. STUDY SELECTION: The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI. DATA EXTRACTION: Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person. RESULTS: Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions. LIMITATIONS: Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies. CONCLUSIONS: More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.

Research priorities in urinary incontinence: results from citizens' juries.

OBJECTIVE: The objective of this study was to elicit research ideas, priorities and outcome measures from women who suffer from urinary incontinence. DESIGN: Citizens' juries gather participants together for a combination of education and deliberation on a specific topic. The juries were held in November 2007. SETTING: Women living in the community with urinary incontinence. SAMPLE: Purposively selected responders to public advertisements in Dunedin, New Zealand, were grouped into two juries dependent on whether stress urinary incontinence or urge urinary incontinence was the predominant problem. METHODS: The juries had a day of education in incontinence and research-related issues, with a half day for deliberation and reporting. MAIN OUTCOME MEASURES: Ideas for areas where research may help the lives of women with incontinence in priority order and how best to measure the outcome of that research. RESULTS: The juries identified five main areas for incontinence research with only minor differences depending on which jury. These are, in priority order, making seeking help easier, making day-to-day life more manageable, finding out total costs, more knowledge about causes and the effects of lifestyle. Quality of life was considered by far the most important outcome. CONCLUSIONS: Citizens' juries are able to come up with ideas for research and prioritise these. Research in the areas suggested would be likely to improve the lives of women with urinary incontinence and may lead to a different mix of research projects than is currently the case.

Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review.

BACKGROUND: Pelvic floor muscle training is the most commonly used physical therapy treatment for stress urinary incontinence. It is sometimes recommended for mixed and less commonly for urge urinary incontinence. OBJECTIVES: The aim of this paper was to determine the effects of pelvic floor muscle training for women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments. METHOD: The Cochrane Incontinence Group Specialized Trials Register was searched up until December 1, 2004. The review included randomized or quasi-randomized trials in women with stress, urge or mixed urinary incontinence. One arm of the trial comprised pelvic floor muscle training, the other comprised either no treatment, placebo, sham, or other inactive control treatment. The trials were independently assessed for eligibility and methodological quality. Data were extracted then cross-checked by the two authors. Disagreements were resolved by discussion. The data were processed as described in the Cochrane Handbook. The trials were sub-grouped by diagnosis. Formal meta-analysis was not undertaken because of study heterogeneity. RESULTS: Thirteen trials involving 714 women met the inclusion criteria; however, only six trials (403 women) contributed to data analysis. CONCLUSION: Overall, the review provides support for the widespread recommendation that pelvic floor muscle training be included in first-line conservative management programs for women with stress, urge or mixed urinary incontinence.

WITHDRAWN: Physical therapies for prevention of urinary and faecal incontinence in adults.

BACKGROUND: Physical therapies, particularly pelvic floor muscle training, have been recommended for prevention of incontinence associated with childbearing, and prostate surgery. OBJECTIVES: To assess the effectiveness of physical therapies in preventing incontinence in adults. SEARCH STRATEGY: The Cochrane Incontinence Group trials register was searched to September 2001. Trials were also sought from the Reference Lists of relevant articles and from experts in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials in adults without incontinence symptoms that compared a physical therapy with no treatment, or any other treatment to prevent incontinence. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Collaboration Handbook. MAIN RESULTS: Two trials in men (155 men) and 13 trials in women (4661 women) were included. As most trials recruited regardless of continence status, and there was much heterogeneity, only a qualitative synthesis was undertaken. Three of seven trials in childbearing women reported less urinary incontinence after pelvic floor muscle training compared to control treatment three months postpartum. Two trials selected women at higher risk of postnatal incontinence. The third used an intensive training programme. Four trials did not find any difference between the groups at the primary endpoint. Two trials compared pre-prostate surgery pelvic floor muscle training with control treatment, and no difference in the occurrence of postoperative urinary incontinence was reported between the groups. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether physical therapies can prevent incontinence in childbearing women, or men following prostate surgery. Further, better quality research is needed.

Anticholinergic drugs versus placebo for overactive bladder syndrome in adults.

BACKGROUND: Around 16% of adults have symptoms of overactive bladder (urgency with frequency and/or urge incontinence). The prevalence increases with age. Anticholinergic drugs are commonly used to treat this condition. OBJECTIVES: To determine the effects of anticholinergic drugs for the treatment of overactive bladder syndrome. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 14 June 2005) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug with placebo treatment or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewer authors independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). MAIN RESULTS: Sixty -one trials, 42 with parallel-group designs and 19 crossover trials were included (11,956 adults). Most trials were described as double-blind but were variable in other aspects of quality. The crossover trials did not present data in a way that allowed inclusion in the meta-analysis. Nine medications were tested: darifenacin; emepronium bromide or carrageenate; oxybutynin; propiverine; propantheline; tolterodine; trospium chloride; and solifenacin. One trial included the newer, slow release formulation of tolterodine. At the end of the treatment period, cure or improvement (relative risk (RR) 1.39, 95% CI 1.28 to 1.51), difference in leakage episodes in 24 hours (weighted mean difference (WMD) -0.54; 95% CI -0.67 to -0.41) and difference in number of voids in 24 hours (WMD -0.69; 95% CI -0.84 to -0.54) were statistically significant favouring medication. Statistically significant but modest sized improvements in quality of life scores were reported in recently completed trials. There was three times the rate of dry mouth in the medication group (RR 3.00 95% CI 2.70 to 3.34) but no statistically significant difference in withdrawal (RR 1.11, 95% CI 0.91 to 1.36). Sensitivity analysis, while limited by small numbers of trials, showed little likelihood that the effects were modified by age, sex, diagnosis, or choice of drug. AUTHORS' CONCLUSIONS: The use of anticholinergic drugs by people with overactive bladder syndrome results in statistically significant improvements in symptoms. Recent trials suggest that this is associated with modest improvement in quality of life. Dry mouth is a common side effect of therapy but did not seem to have an effect on the numbers of withdrawals. It is not clear whether any benefits are sustained during long-term treatment or after treatment stops.

The assessment of levator trauma: a comparison between palpation and 4D pelvic floor ultrasound.

AIMS: Major morphological abnormalities of the pubovisceral muscle are observed in 10-20% of women symptomatic of pelvic floor disorders. Such defects arise in childbirth and are associated with prolapse. While they are clearly evident on 3D ultrasound and MR imaging, such defects can be difficult to detect clinically. We intended to compare findings on palpation with the results of ultrasound imaging. MATERIAL AND METHODS: Fifty-five women were recruited in a prospective observational study and assessed by interview, vaginal examination by a trained pelvic floor physiotherapist, and 3D/4D pelvic floor ultrasound. The vaginal examination involved digital assessment of muscle strength (modified Oxford grading) and morphological abnormalities. The ultrasound examination involved acquisition of volume datasets taken at rest, on Valsalva and pelvic floor muscle contraction. Assessments were undertaken supine and after voiding. Ultrasound operator and physiotherapist were blind to each other's findings. RESULTS: A comparison of 3D ultrasound and palpation was possible in 54 cases. Average Oxford grading was weakly associated with reduction in hiatal dimensions on contraction (r = -0.32, P = 0.024). A marked increase in hiatal dimensions detected on palpation was associated with increased hiatal area on Valsalva (P = 0.027). Defects were observed in 7/54 (13%) on ultrasound and in 10/55 (18%) on palpation. There was poor agreement between the methods, with only two defects picked up equally by both methods. CONCLUSIONS: Palpation of the pubovisceral muscle correlates poorly with 3D/4D pelvic floor ultrasound imaging for the assessment of muscular defects.

Which anticholinergic drug for overactive bladder symptoms in adults.

BACKGROUND: Around 16% to 45% of adults have overactive bladder symptoms (urgency with frequency and/or urge incontinence - 'overactive bladder syndrome'). Anticholinergic drugs are common treatments. OBJECTIVES: To compare the effects of different anticholinergic drugs for overactive bladder symptoms. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised trials register (searched 17 January 2002) and reference lists of relevant articles. A search for full publications of abstracts identified in January 2002 was completed in July 2003. SELECTION CRITERIA: Randomised trials in adults with overactive bladder symptoms or detrusor overactivity that compared one anticholinergic drug with another, or two doses of the same drug. DATA COLLECTION AND ANALYSIS: Two authors independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Reviewers' Handbook. MAIN RESULTS: Forty nine trials, 39 parallel and 10 cross-over designs were included (11,332 adults). Most trials were described as double-blind, but were variable in other aspects of quality. Crossover studies did not present data in a way that could be included in the meta-analysis.Four trials collected quality of life data (the primary outcome measure) using validated measures; none reported useable data. Oxybutynin versus tolterodine: There were no statistically significant differences for patient perceive improvement, leakage episodes or voids in 24 hours, but fewer withdrawals due to adverse events (RR 0.57, 95% CI 0.43 to 0.75), and less risk of dry mouth (RR 0.60, 95% CI 0.54 to 0.66), with tolterodine. Different doses tolterodine: The usual recommended starting dose (2 mg twice daily) was compared with two lower (0.5 mg and 1 mg twice daily), and one higher dose (4 mg twice daily). The effect of 1 mg, 2 mg and 4 mg doses was similar for leakage episodes and micturitions in 24 hours, with greater risk of dry mouth with 2 and 4 mg doses.Extended versus immediate release preparations of oxybutynin and/or tolterodine: There were no statistically significant differences for cure/improvement, leakage episodes or micturitions in 24 hours, or withdrawals due to adverse events, but there were few data. Overall, extended release preparations had less risk of dry mouth. One extended release preparation versus another: There was less risk of dry mouth with oral extended release tolterodine than oxybutynin (RR 0.75, 95% CI 0.59 to 0.95), but no difference between transdermal oxybutynin and oral extended release tolterodine although some people withdrew due to skin reaction at the trandermal patch site. AUTHORS' CONCLUSIONS: Where the prescribing choice is between oral immediate release oxybutynin or tolterodine, tolterodine might be preferred for reduced risk of dry mouth. With tolterodine, 2 mg twice daily is the usual starting dose, but a 1 mg twice daily dose might be equally effective with less risk of dry mouth. If extended release preparations of oxybutynin or tolterodine are available, these might be preferred to immediate release preparations because there is less risk of dry mouth. There is little or no evidence available about quality of life, costs, or long-term outcome in these studies. There were insufficient data from trials of other anticholinergic drugs to draw any conclusions.

Anticholinergic drugs versus placebo for overactive bladder syndrome in adults.

BACKGROUND: Around 16% of adults have symptoms of overactive bladder (urgency with frequency and/or urge incontinence). The prevalence increases with age. Anticholinergic drugs are commonly used to treat this condition. OBJECTIVES: To determine the effects of anticholinergic drugs for the treatment of overactive bladder syndrome. SEARCH STRATEGY: The Cochrane Incontinence Group trials register was searched to January 2002. SELECTION CRITERIA: Randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug with placebo treatment or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Collaboration Handbook. MAIN RESULTS: Fifty one trials, 32 parallel designs and 19 crossover designs were included (6713 adults). Most trials were described as double-blind, but were variable in other aspects of quality. The crossover trials did not present data in a way that allowed inclusion in the meta-analysis. Seven medications were tested: darifenacin; emepronium bromide or carrageenate; oxybutynin chloride; propiverine; propantheline; tolterodine; and trospium chloride. One trial included the newer, slow release, formulation of tolterodine. After treatment, cure/improvement (RR 1.41, 95%CI 1.29 to 1.54), changes in leakage episodes in 24 hours (WMD -0.56, 95%CI -0.73 to -0.39), number of voids in 24 hours (WMD -0.59, 95%CI -0.83 to -0.36), maximum cystometric volume (WMD 53.85 ml, 95%CI 42.28 to 65.41), and volume at first contraction (WMD 52.25 ml, 95%CI 37.45 to 67.06), were significantly in favour of medication. Medication was associated with significantly higher residual volumes (WMD 4.06 ml, 95%CI 0.73 to 7.39) and more than two and a half times the rate of dry mouth (RR 2.61, 95% CI 2.27 to 3.00). Sensitivity analysis, while limited by small numbers of trials, showed little likelihood that these effects were modified by age, sex, diagnosis, or choice of drug. REVIEWER'S CONCLUSIONS: The use of anticholinergic drugs by people with overactive bladder syndrome results in statistically significant improvement in symptoms. However, the clinical significance of these differences is uncertain, and the longer-term effects are not known. Dry mouth is a common side effect of therapy.

Physical therapies for prevention of urinary and faecal incontinence in adults.

BACKGROUND: Physical therapies, particularly pelvic floor muscle training, have been recommended for prevention of incontinence associated with childbearing, and prostate surgery. OBJECTIVES: To assess the effectiveness of physical therapies in preventing incontinence in adults. SEARCH STRATEGY: The Cochrane Incontinence Group trials register was searched to September 2001. Trials were also sought from the Reference Lists of relevant articles and from experts in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials in adults without incontinence symptoms that compared a physical therapy with no treatment, or any other treatment to prevent incontinence. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Collaboration Handbook. MAIN RESULTS: Two trials in men (155 men) and 13 trials in women (4661 women) were included. As most trials recruited regardless of continence status, and there was much heterogeneity, only a qualitative synthesis was undertaken. Three of seven trials in childbearing women reported less urinary incontinence after pelvic floor muscle training compared to control treatment three months postpartum. Two trials selected women at higher risk of postnatal incontinence. The third used an intensive training programme. Four trials did not find any difference between the groups at the primary endpoint. Two trials compared pre-prostate surgery pelvic floor muscle training with control treatment, and no difference in the occurrence of postoperative urinary incontinence was reported between the groups. REVIEWER'S CONCLUSIONS: There is insufficient evidence to determine whether physical therapies can prevent incontinence in childbearing women, or men following prostate surgery. Further, better quality research is needed.