Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women.
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PROVIDER: S-EPMC6516955 | BioStudies |
REPOSITORIES: biostudies
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Project description: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.
| S-EPMC6428911 | BioStudies
Project description: Not available
| S-EPMC7203602 | BioStudies
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.
| S-EPMC4141945 | BioStudies
Project description:<h4>Introduction and hypothesis</h4>The aim of this study was to prospectively identify aspects of baseline demographic, clinical, and pelvic morphology of women with stress urinary incontinence (SUI) that are predictive of cure with physiotherapist-supervised pelvic floor muscle training (PFMT).<h4>Methods</h4>Women ?18 years old with SUI were recruited from urogynecology and pelvic health physiotherapy clinics. Participants completed a 3-day bladder diary, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), a standardized pad test, manual assessment of pelvic floor muscle (PFM) strength and tone, and transperineal ultrasound (TPUS) assessment of their urogenital structures at rest while in a supine position and standing, and during contraction, straining, and coughing. Participants attended six physiotherapy sessions over 12 weeks and performed a home PFMT program. The assessment was repeated after the intervention; cure was defined as a dry (?2 g) pad test.<h4>Results</h4>Seventy-seven women aged 50 (±10) years completed the protocol; 38 (49%) were deemed cured. Based on univariate testing, four predictors were entered into a binary logistic regression model: ICIQ-UI-SF, PFM tone, bladder neck (BN) height in a quiet standing position, and BN height during a cough in a standing position. The model was significant (p?<?0.001), accurately classifying outcome in 74% of participants. The model, validated through bootstrapping, performed moderately, with the area under the receiver operating characteristic curve = 0.80 (95% CI: 0.69-0.90; p?=?0.00), and with 70% sensitivity and 75% specificity.<h4>Conclusions</h4>Women with better bladder support in a standing position and less severe symptoms were most likely to be cured with PFMT.<h4>Clinical trial registration</h4>#NCT01602107.
| S-EPMC7902568 | BioStudies
Project description:<h4>Background</h4>Stress urinary incontinence (SUI) is a prevalent and costly condition which may be treated surgically or by physical therapy. The aim of this review was to systematically assess the literature and present the best available evidence for the efficacy and effectiveness of pelvic floor muscle training (PFMT) performed alone and together with adjunctive therapies (eg biofeedback, electrical stimulation, vaginal cones) for the treatment of female SUI.<h4>Methods</h4>All major electronic sources of relevant information were systematically searched to identify peer-reviewed English language abstracts or papers published between 1995 and 2005. Randomised controlled trials (RCTs) and other study designs eg non-randomised trials, cohort studies, case series, were considered for this review in order to source all the available evidence relevant to clinical practice. Studies of adult women with a urodynamic or clinical diagnosis of SUI were eligible for inclusion. Excluded were studies of women who were pregnant, immediately post-partum or with a diagnosis of mixed or urge incontinence. Studies with a PFMT protocol alone and in combination with adjunctive physical therapies were considered. Two independent reviewers assessed the eligibility of each study, its level of evidence and the methodological quality. Due to the heterogeneity of study designs, the results are presented in narrative format.<h4>Results</h4>Twenty four studies, including 17 RCTs and seven non-RCTs, met the inclusion criteria. The methodological quality of the studies varied but lower quality scores did not necessarily indicate studies from lower levels of evidence. This review found consistent evidence from a number of high quality RCTs that PFMT alone and in combination with adjunctive therapies is effective treatment for women with SUI with rates of 'cure' and 'cure/improvement' up to 73% and 97% respectively. The contribution of adjunctive therapies is unclear and there is limited evidence about treatment outcomes in primary care settings.<h4>Conclusion</h4>There is strong evidence for the efficacy of physical therapy for the treatment for SUI in women but further high quality studies are needed to evaluate the optimal treatment programs and training protocols in subgroups of women and their effectiveness in clinical practice.
| S-EPMC1586224 | BioStudies
Project description:<h4>Importance</h4>Urinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear.<h4>Objective</h4>To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.<h4>Design, setting, and participants</h4>The Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled.<h4>Interventions</h4>After an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184).<h4>Main outcomes and measures</h4>The primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used.<h4>Results</h4>Among 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon.<h4>Conclusions and relevance</h4>Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT02039830.
| S-EPMC7400216 | BioStudies
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.
| S-EPMC4647572 | BioStudies
Project description:OBJECTIVE:To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN:Parallel group randomised controlled trial. SETTING:23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS:600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS:Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES:The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS:Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS:At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION:ISRCTN57756448.
| S-EPMC7555069 | BioStudies
Project description:BACKGROUND:Childbirth is a major risk factor for urinary incontinence (UI). As a result, pelvic floor muscle training (PFMT) is commonly recommended during and after pregnancy to prevent the onset of UI. PFMT is often classed as a physical activity (PA) behaviour, hence PA guidelines for postnatal women encourage PFMT alongside aerobic activities. However, postnatal lifestyle interventions tend to overlook PFMT which can be detrimental to women's health and future health risks, including urinary incontinence. This study aimed to explore perceptions and acceptability of a postnatal physical activity and PFMT intervention with postnatal women in Scotland. METHODS:We recruited women who had given birth within the last 5 years by displaying posters in health centres and community centres in Stirling and through Facebook. Data was gathered via online and face-to-face focus groups, that were audio recorded and transcribed verbatim. Analytic themes were initially organised under related concepts derived from the topic guide and thematic analysis conducted. Subsequent analysis was by the Framework technique. RESULTS:A total of seven online and face-to-face focus group discussions with 31 women identified there was a clear intention behaviour gap for engagement in PA, with both psychological and logistical barriers identified such as motivation and childcare. This was distinct from PFMT where there was a feeling of helplessness around not knowing how to perform a correct PFMT contraction subsequently resulting in women not adhering to PFMT guidance. Women felt there was no accessible PFMT advice available through the NHS. Some participants had received PFMT advice after childbirth and spoke of the Squeezee app being useful in adhering to a PFMT regimen but they did require additional teaching on how to do correct contractions. There was need for clarity and practical support for PFMT in the postnatal period with an approved intervention incorporating an accessible app being suggested by participants. CONCLUSIONS:Women would like to be trained on postnatal PFMT but face barriers to accessing adequate information and education on how to do a PFMT contraction. An intervention combining PFMT training and an app would be the most useful for their needs and circumstances.
| S-EPMC6967084 | BioStudies
Project description:INTRODUCTION:There is a lack of published studies about the combination of duloxetine and pelvic floor muscle training (PFMT) in women with stress urinary incontinence (SUI). The aim of our work will be to evaluate the effect of this intervention by assessing whether there is a change in the incontinence episode frequency (IEF), Incontinence Quality of Life (I-QoL), Patient Global Impression of Improvement score (PGI-I) and mean time between voids (MTBV). Combined therapy with duloxetine and PFMT will be compared to duloxetine treatment alone with respect to its efficacy and side effects. METHODS:This study will be a randomized intervention, parallel, multicenter study in collaboration with 45 urological outpatient clinics at the national level. Patients will be assigned in a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even numbers assigned sequentially to the patients at each clinic. The experimental intervention will be 12 weeks. The experimental group will receive oral treatment with duloxetine at a daily dose of 2 × 40?mg and will be required to perform innovative PFMT. The control group will receive the same oral duloxetine treatment (2 × 40?mg a day) but will not perform PMFT. Data will be collected from both groups before intervention and after the 12-week intervention is completed. DISCUSSION:The study protocol presents the starting points, design and randomization of an interventional multicenter study to monitor the effect of the combination of duloxetine with innovative PFMT compared to duloxetine treatment alone in women with SUI. This study may provide evidence of the efficacy of this combined treatment for SUI and highlight benefits associated with active approaches to treatment through exercise. REGISTRATION:This study was retrospectively registered in the ClinicalTrials.go NCT04140253. Protocol version 1.0. date 11.1.2019.
| S-EPMC7015553 | BioStudies