Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a cochrane systematic review abridged republication.
ABSTRACT: BACKGROUND:Pelvic floor muscle training is the most commonly used physical therapy treatment for women with urinary incontinence. OBJECTIVES:To assess the effects of Pelvic floor muscle training for women with urinary incontinence in comparison to a control treatment and to summarize relevant economic findings. METHODS:Cochrane Incontinence Group Specialized Register (February 12, 2018). SELECTION CRITERIA:Randomized or quasi-randomized trials in women with stress, urgency or mixed urinary incontinence (symptoms, signs, or urodynamic). DATA COLLECTION AND ANALYSIS:Trials were independently assessed by at least two reviewers authors and subgrouped by urinary incontinence type. Quality of evidence was assessed by adopting the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULTS:The review included thirty-one trials involving 1817 women from 14 countries. Overall, trials were small to moderate size, and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration. Based on data available, we can be confident that Pelvic floor muscle training can cure or improve symptoms of stress and all other types of urinary incontinence. It may reduce the number of leakage episodes and the quantity of leakage, while improving reported symptoms and quality of life. Women were more satisfied with Pelvic floor muscle training, while those in control groups were more likely to seek further treatment. Long-term effectiveness and cost-effectiveness of Pelvic floor muscle training needs to be further researched. CONCLUSIONS:The addition of ten new trials did not change the essential findings of the earlier review, suggesting that Pelvic floor muscle training could be included in first-line conservative management of women with urinary incontinence.
Project description:BACKGROUND: In women with mixed urinary incontinence, pelvic floor muscle training and solifenacin is the recommended conservative treatment, while electroacupuncture is a safe, economical and effective option. METHODS/DESIGN: In this prospective, multi-center, randomized controlled trial, five hundred women with mixed urinary incontinence, from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin. Women in the acupuncture group will receive electroacupuncture for 3 sessions per week, over 12 weeks, while women in the control group will receive pelvic floor muscle training plus solifenacin (5 mg once daily) for 36 weeks. The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12. The secondary outcome measures include eleven items, including proportion of participants with ≥50% decrease in average 72-h incontinence episode frequency, change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25-36, and so forth. Statistical analysis will include covariance analysis, nonparametric tests and t tests. DISCUSSION: The objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02047032.
Project description:Previous research has shown that electroacupuncture therapy has a potential therapeutic effect for simple female stress urinary incontinence. In this study, pelvic floor muscle training, the first-line treatment for stress urinary incontinence in women based on meta-analysis of numerous randomized control trials and recommended by international clinical practice, is used as a control group to demonstrate whether electroacupuncture therapy is a better method for female stress urinary incontinence.A randomized controlled trial has been designed to evaluate the therapeutic benefit of electroacupuncture for female stress urinary incontinence compared with pelvic floor muscle training. The safety of electroacupuncture and patient compliance will also be evaluated. Untoward reaction to the electroacupuncture, including a broken needle, fainting on acupuncture, or pain during acupuncture, will be recorded and the therapy will be stopped if an untoward reaction occurs. After we have received full ethical approval and patient consent, participants will be randomized to receive a series of 24 electroacupuncture or pelvic floor muscle training interventions. The frequency and amount of leakage will be measured as the primary outcome parameters. Secondary outcome parameters include the 1-hour pad test, the short-form of the International Consultation on Incontinence Questionnaire, patient subjective effectiveness evaluation, weekly usage of pad, and usage of specialty therapy for female stress urinary incontinence.This trial will help to determine whether electroacupuncture is a more effective treatment than pelvic floor muscle training for patients with female stress urinary incontinence.ClinicalTrials.gov NCT01940432 (12 September 2013).
Project description:The aim of this study was to compare the effect of pelvic floor muscle training with surface electromyographic (sEMG) biofeedback (BF group) and Pilates exercises (P group) on the bioelectrical activity of pelvic floor muscles in women with stress urinary incontinence. The other aim aim was to compare changes in voiding diaries and scores on quality of life questionnaire against baseline values and between the groups. Women in the BF group (n = 18) participated in pelvic floor muscle training with sEMG biofeedback; the P group (n = 13) participated in basic level Pilates workouts. Both protocols were continued for eight weeks. Voiding diary, quality of life and electromyographic characteristics of the pelvic floor muscles were assessed at the three-time points: at baseline, after eight weeks' training, and at month six post-training. The sEMG activity of the pelvic floor muscles was tested during five trials in two positions. There was no marked improvement in bioelectrical activity of the pelvic floor muscles during contraction following training with sEMG biofeedback or Pilates exercises. Following eight weeks of sEMG biofeedback training, a decrease was noted in resting bioelectrical activity of pelvic floor muscles and during relaxation after sustained contraction but only in supine-lying. No such effect was observed in the Pilates group. In the BF group, the number of incontinence episodes after end of treatment (timpepoints: 1vs. 2) and at six month follow-up (timpepoints: 1vs. 3) decreased by 68.5% and 89.3%, respectively. The respective values in the P group were 78.6%, and 86.4%. The intergroup differences did not reach the level of statistical significance. As regards the quality of life, the questionnaire demonstrated that Pilates exercises had significantly better effects compared to biofeedback training both at the end of the eight-week exercise program and (p = 0.003) and at six month follow-up (p = 0.0009). The International Consultation on Incontinence Questionnaire-Short Form (ICIQ- SF) showed comparable efficacy of Pilates exercises and training with sEMG biofeedback. Intragroup improvements in micturition frequency, incontinence (leakage) episodes, and nocturia frequency were comparable. Alleviation of urinary incontinence symptoms was comparable in both groups, whereas the improvement in the quality of life was more notable in the Pilates group. The obtained results failed to demonstrate the superiority of any of the two methods regarding the bioelectrical activity of pelvic floor muscles in patients with stress urinary incontinence.
Project description:The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI).Change in symptom and condition-specific health-related quality-of-life (HRQOL) measures were compared between pessary and behavioral groups 3 months after randomization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial. Four hundred forty-six women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary, prolapse, and colorectal scales of the Pelvic Floor Distress Inventory; urinary, prolapse, and colorectal scales of the Pelvic Floor Impact Questionnaire; and Stress and Urge scales of the Questionnaire for Urinary Incontinence Diagnosis. Student t test and analysis of variance were used to compare scores within and between groups.Mean age of participants was 49.8 (SD, 11.9) years; 84% were white, and 10% were African American. One hundred forty-nine were randomized to pessary, and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after randomization, but there was no statistically significant difference between groups.There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI.
Project description:Urge urinary incontinence is a major problem, especially in the elderly, and to our knowledge the underlying mechanisms of disease and therapy are unknown. We used biofeedback assisted pelvic floor muscle training and functional brain imaging (functional magnetic resonance imaging) to investigate cerebral mechanisms, aiming to improve the understanding of brain-bladder control and therapy.Before receiving biofeedback assisted pelvic floor muscle training functionally intact, older community dwelling women with urge urinary incontinence as well as normal controls underwent comprehensive clinical and bladder diary evaluation, urodynamic testing and brain functional magnetic resonance imaging. Evaluation was repeated after pelvic floor muscle training in those with urge urinary incontinence. Functional magnetic resonance imaging was done to determine the brain reaction to rapid bladder filling with urgency.Of 65 subjects with urge urinary incontinence 28 responded to biofeedback assisted pelvic floor muscle training with 50% or greater improvement of urge urinary incontinence frequency on diary. However, responders and nonresponders displayed 2 patterns of brain reaction. In pattern 1 in responders before pelvic floor muscle training the dorsal anterior cingulate cortex and the adjacent supplementary motor area were activated as well as the insula. After the training dorsal anterior cingulate cortex/supplementary motor area activation diminished and there was a trend toward medial prefrontal cortex deactivation. In pattern 2 in nonresponders before pelvic floor muscle training the medial prefrontal cortex was deactivated, which changed little after the training.In older women with urge urinary incontinence there appears to be 2 patterns of brain reaction to bladder filling and they seem to predict the response and nonresponse to biofeedback assisted pelvic floor muscle training. Moreover, decreased cingulate activation appears to be a consequence of the improvement in urge urinary incontinence induced by training while prefrontal deactivation may be a mechanism contributing to the success of training. In nonresponders the latter mechanism is unavailable, which may explain why another form of therapy is required.
Project description:AIMS:The primary aim is to provide detailed rationale and methodology for the development and implementation of a perioperative behavioral/pelvic floor exercise research protocol for women who self-chose surgical intervention and who may or may not have been offered behavioral treatments initially. This protocol is part of the ESTEEM trial (Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence Trial) which was designed to determine the effect of a combined surgical and perioperative behavioral/pelvic floor exercise intervention versus surgery alone on improving mixed urinary incontinence (MUI) and overactive bladder (OAB) symptoms. METHODS:As part of a multi-site, prospective, randomized trial of women with MUI electing midurethral sling (MUS) surgical treatment, participants were randomized to a standardized perioperative behavioral/pelvic floor exercise intervention?+?MUS versus MUS alone. The specific behavioral intervention included: education on voiding habits, pelvic floor muscle training (PFMT), bladder training (BT), strategies to control urgency and reduce/prevent urinary symptoms, and monitoring/promoting adherence to behavioral recommendations. To ensure consistency across all eight research sites in the pelvic floor disorders network (PFDN), selective behavioral treatments sessions were audiotaped and audited for protocol adherence. RESULTS:The behavioral intervention protocol includes individualization of interventions using an algorithm based on pelvic floor muscle (PFM) assessment, participant symptoms, and findings from the study visits. We present, here, the specific perioperative behavioral/pelvic floor exercise interventions administered by study interventionists. CONCLUSIONS:This paper details a perioperative behavioral/pelvic floor exercise intervention research study protocol developed for women undergoing surgery for MUI.
Project description:<b>Background: </b>There is ample evidence that gestational diabetes mellitus has a direct influence on urinary incontinence and pelvic floor muscles. There are no standardized pelvic floor muscle exercise programs in the literature for the physiotherapy and differ in the type of exercise, intensity, type and duration of application, and the frequency and duration of treatment sessions. The aim of this systematic review will be to investigate that Pelvic Floor Muscle Training can prevent and/or decrease the pregnancy specific urinary incontinence in women with gestational diabetes mellitus or gestational hyperglycemia.<br><br><b>Methods: </b>We will perform a systematic review according to the Cochrane methodology of Randomized Controlled Trials. An overall search strategy will be developed and adapted for Embase, MEDLINE, LILACS, and CENTRAL databases, with the date of consultation until June 2020. The MeSH terms used will be "Pregnancy", "Hyperglycemia", "Diabetes Mellitus, Type 2", "Diabetes Mellitus, Type 1", "Pregnancy in Diabetics", "Diabetes, Gestational", "Urinary Incontinence", "Pelvic Floor Muscle Strength". Primary outcomes: improvement or cure of pregnancy specific urinary incontinence (which can be assessed by questionnaires, and tools such as tampon test, voiding diary, urodynamic study). Secondary outcomes: improvement of pelvic floor muscle strength (pelvic floor functional assessment, perineometer, electromyography, functional ultrasonography), improved quality of life (questionnaires), presence or absence of postpartum Urinary Incontinence and adverse effects. Quality assessment by Cochrane instrument. Metanalysis if plausible, will be performed by the software Review Manager 5.3.<br><br><b>Discussion: </b>The present study will be the first to analyze the effectiveness of pelvic floor exercises in pregnant women with Gestational Diabetes Mellitus or Hyperglycemia, who suffer from pregnancy specific urinary incontinence. Randomized Controlled Trials design will be chosen because they present the highest level of evidence. It is expected to obtain robust and conclusive evidence to support clinical practice, in addition to promoting studies on the theme and contributing to new studies.<br><br><b>Trial registration: </b>Systematic review registration: PROSPERO CRD42017065281.
Project description:Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied.This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.
Project description:<h4>Objective</h4>To determine the long term effects of a conservative nurse-led intervention for postnatal urinary incontinence.<h4>Design</h4>Randomised controlled trial.<h4>Setting</h4>Community based intervention in three centres in the United Kingdom and New Zealand.<h4>Participants</h4>747 women with urinary incontinence at three months after childbirth, of whom 516 were followed up again at 6 years (69%).<h4>Intervention</h4>Active conservative treatment (pelvic floor muscle training and bladder training) at five, seven, and nine months after delivery or standard care.<h4>Main outcome measures</h4>Urinary and faecal incontinence, performance of pelvic floor muscle training.<h4>Results</h4>Of 2632 women with urinary incontinence, 747 participated in the original trial. The significant improvements relative to controls in urinary (60% v 69%) and faecal (4% v 11%) incontinence at one year were not found at six year follow up (76% v 79% (95% confidence interval for difference in means -10.2% to 4.1%) for urinary incontinence, 12% v 13% (-6.4% to 5.1%) for faecal incontinence) irrespective of subsequent obstetric events. In the short term the intervention had motivated more women to perform pelvic floor muscle training (83% v 55%) but this fell to 50% in both groups in the long term. Both urinary and faecal incontinence increased in prevalence in both groups during the study period.<h4>Conclusions</h4>The moderate short term benefits of a brief nurse-led conservative treatment of postnatal urinary incontinence may not persist, even among women with no further deliveries. About three quarters of women with urinary incontinence three months after childbirth still have this six years later.
Project description:<h4>Background</h4>We aim to evaluate if Pelvic Floor Muscle Training (PFMT) delivered in primary care results in fewer referrals to secondary care for urinary incontinence (UI), thereby reducing the number and associated costs of surgical procedures for UI. Methods / design: The study will consist of two populations - a prevention group and a treatment group who will both be offered PFMT in primary care. The prevention group will consist of parous women aged 25-64 attending for a routine cervical smear. Their pelvic floor will be assessed using the Modified Oxford Scale (MOS) and a baseline data form will be completed that asks about the frequency and associated bother of urine leakage. From the answers given, the group will be subdivided into two groups. The first (prevention) group will be subdivided into a primary prevention arm (no symptoms of urinary incontinence and pelvic floor strength ?2 on MOS) and a secondary prevention arm (women reporting symptoms of urine leakage irrespective of MOS). The second (treatment) group will be women of any age who may or may not have had a vaginal birth presenting to their GP with UI. Semi-structured, in-depth interviews will be conducted with a subset of patients and staff with the aim of identifying barriers and facilitators in delivering PFMT in primary care.<h4>Discussion</h4>A recently completed community study showed good outcomes with practice nurse delivery of PFMT. We suggest if this were to be implemented more widely it would reduce the need for referral to secondary care. We believe that this study will show whether implementing a package of PFMT delivered in primary care can treat as well as prevent UI and will also be helpful in exploring the benefits / drawbacks of such implementation, thus providing lessons for implementation in other Primary Care Trusts (PCTs).