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Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Luginbuehl H

PROVIDER: S-EPMC4647572 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial.

Luginbuehl Helena H Lehmann Corinne C Baeyens Jean-Pierre JP Kuhn Annette A Radlinger Lorenz L

Trials 20151117

<h4>Background</h4>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 implement ...[more]

PMID: 26573847

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Project description:Introduction and hypothesisAlthough involuntary reflexive pelvic floor muscle contractions seem crucial during stress urinary incontinence-provoking situations, hitherto existing guidelines feature voluntary pelvic floor muscle training only. Two pelvic floor muscle protocols were compared regarding their effect on stress urinary incontinence in women: one focusing on standard physiotherapy with voluntary pelvic floor muscle training, the other additionally including involuntary reflexive pelvic floor muscle training.MethodsThis study was designed as a triple-blind prospective randomized controlled trial with women suffering from stress urinary incontinence with two physiotherapy intervention groups (control group: standard physiotherapy, n = 48, experimental group: standard physiotherapy plus involuntary reflexive pelvic floor muscle training triggered by whole-body movements such as jumps n = 48). Both interventions lasted 16 weeks (9 personal physiotherapy consultations and 78 home training sessions). Group differences and development over time were analyzed concerning the primary outcome International Consultation on Incontinence Modular Questionnaire Urinary Incontinence short form (ICIQ-UIsf) by mixed effect regression models.ResultsThe ICIQ-UIsf score decreased significantly over time for both groups by about 3 points from about 10 to about 7 points with no group differences at any point in time.DiscussionThis trial did not find any additional benefit for stress urinary incontinence by adding involuntary reflexive pelvic floor muscle training to standard training. Both training protocols showed similar clinically relevant improvements; however, there was still moderate incontinence after interventions. Future studies should test and apply pelvic floor muscle function-oriented training methods for pelvic floor muscle hypertrophy, intramuscular coordination, and power, which are more in line with conventional skeletal muscle training, i.e., performed with higher intensities and workout.

Project description:BackgroundPelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms: 'Enhanced Pelvic Floor Muscle Strength,' 'Maximized Awareness of Timing,' and 'Strengthened Core Muscles'. The purpose of this scoping review was to systematically map evidence for and against theorized mechanisms through which pelvic floor muscle training interventions work to reduce urinary incontinence in women.MethodsThe scoping review is based upon a comprehensive search of relevant literature published from 1990 to 2020 in PubMed, CINAHL, PsycINFO, ClinialTrials.gov, reference lists from review articles, and hand searches of articles by known researchers in the field. We included English-language, peer-reviewed articles on pelvic floor muscle training as an intervention for adult women if they provided empirical evidence to testing the theorized intervention mechanisms. Two independent reviewers screened articles for inclusion and extracted data to describe details of each study (author, year, country, design, sampling), measures of pelvic floor muscle strength and urinary incontinence, statistical analysis of linkage between changes in the measures, and pelvic floor muscle training regimens. Data were summarized to facilitate the integration of diverse evidence to draw conclusions on supporting or refuting the three proposed theorized mechanisms for managing urinary incontinence in women.ResultsOf the 278 articles identified with the search, 13 (4.7%) met inclusion criteria. There was weak to no evidence for the mechanism of enhanced pelvic floor muscle strength, equivocal support for maximized awareness of timing, and no evidence for strengthened core muscles.ConclusionsThis review revealed extremely limited data supporting the proposed theorized mechanisms underlying pelvic floor muscle training programs to manage urinary incontinence in women. Such evidence is needed to help women and clinicians understand how, why and when a woman benefits from pelvic floor muscle training. Future studies should specifically state and report statistical analysis that relates the theorized mechanisms to the training outcomes observed.

Project description:BackgroundTo date, the focus of pelvic floor muscle training for women suffering from stress urinary incontinence has been on voluntary contractions although involuntary pelvic floor muscle contractions are crucial to guarantee continence in high-impact situations typically triggering this condition. The authors developed 2 pelvic floor muscle home training programs, one including standard voluntary pelvic floor muscle training and one including involuntary reflexive pelvic floor muscle training.ObjectiveThis study aimed to test 2 pelvic floor muscle home training programs regarding maintenance of effects of a previous 16-week intervention in terms of stress urinary incontinence symptoms (International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form, modified 20-minute pad test), impact on quality of life (Lower Urinary Tract Symptoms Quality of Life module), and digitally assessed pelvic floor muscle strength.Study designThis trial was a continuation of a previously published triple-blind prospective randomized controlled trial with a 6-month evaluation endpoint with 2 intervention groups (experimental group with involuntary reflexive home pelvic floor muscle training and control group with standard voluntary home pelvic floor muscle training).ResultsFrom the originally included 96 randomized and allocated participants (experimental group=46, control group=46), 33 control and 27 experimental participants completed the 6-month follow-up. From post-16-week physiotherapy intervention to 6-month follow-up (home pelvic floor muscle training), there were statistically significant improvements in pelvic floor muscle strength (control and experimental group), and no difference in the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence short form and pad test, or the Lower Urinary Tract Symptoms Quality of Life module Part B (control and experimental group) and Part A (control group). However, there was a statistically significant improvement in the Lower Urinary Tract Symptoms Quality of Life module Part A (experimental group). At no point in time (pre, post, follow-up) was there any statistically significant difference between the groups.ConclusionBoth groups could maintain their intervention training effects. This trial investigated involuntary reflexive pelvic floor muscle training alone, which proved to be an effective alternative to standard voluntary pelvic floor muscle training for maintenance of training effects among women suffering from stress urinary incontinence.

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.

Dataset Information

Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial.

Publications

Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial.

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