Dataset Information

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

ABSTRACT:

Introduction and hypothesis

Although 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.

Methods

This 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.

Results

The 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.

Discussion

This 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.

SUBMITTER: Luginbuehl H

PROVIDER: S-EPMC8885550 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Luginbuehl Helena H Lehmann Corinne C Koenig Irene I Kuhn Annette A Buergin Reto R Radlinger Lorenz L

International urogynecology journal 20210210 3

<h4>Introduction and hypothesis</h4>Although 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 reflexi ...[more]

PMID: 33566173

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Project description:BackgroundPelvic 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.Methods/designThe 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.DiscussionThis 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.Trial registrationNCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.

Project description:ImportanceSupervised pelvic floor muscle training (PFMT) has been recommended as the first-line treatment for women with stress urinary incontinence (SUI), but more evidence on whether adjunctive methods would provide additional benefits is needed.ObjectiveTo compare the efficacy of PFMT with or without a home-based pressure-mediated biofeedback (BF) device.Design, setting, and participantsThis multicenter assessor-blinded randomized clinical trial was conducted in the obstetric clinics of 5 participating tertiary hospitals in China. Participants included eligible women with new-onset postpartum SUI who were enrolled from March 28, 2022, to October 13, 2023.InterventionAll participants received 3 months of supervised PFMT and were randomized to either the intervention (PFMT with a home-based pressure-mediated BF device) or the control group (home-based PFMT).Main outcome and measuresThe primary outcome was the severity of urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form after 3 months of supervised PFMT. The secondary outcomes included the cure and improvement rates, PFM strength, quality of life, self-efficacy, and adherence.ResultsA total of 452 participants (median age, 34 [IQR, 31-36] years; median body mass index [calculated as the weight in kilograms divided by the height in square meters], 23.71 [IQR, 21.37-25.97]; median time since delivery, 50 [IQR, 43-61] days) were included in the analysis, with 223 in the intervention group and 229 in the control group. Compared with the control group, the intervention group achieved a significantly greater reduction in incontinence severity (median, 3.00 [IQR, 1.00-6.00] vs 2.00 [IQR, 0-4.00] points; z = -3.05; P = .002), significantly increased cure rate (45 of 223 [20.2%] vs 20 of 229 [8.7%]; z = 12.02; P = .001) and improvement (132 of 223 [59.2%] vs 102 of 229 [44.5%]; z = 9.71; P = .002), significantly greater pelvic floor muscle strength (median, 26.00 [IQR, 17.00-38.00] vs 21.00 [IQR, 13.50-33.50] cm H2O; z = -2.28; P = .02), and a significantly greater correlation between subjective and objective adherence (r = 0.825 vs r = 0.627).Conclusion and relevanceIn this randomized clinical trial, the efficacy of pressure-mediated BF combined with PFMT was superior to that of PFMT alone. These findings support the use of pressure-mediated BF devices for improving treatment outcomes for patients with SUI.Trial registrationClinicalTrials.gov Identifier: NCT05115864.

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.

Project description:UnlabelledWHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Stress urinary incontinence (SUI) affects 10-35% of women, and it is sometimes very distressful. Pelvic floor exercises are the first line of treatment, but access barriers or embarrassment may prevent women from seeking help. There is a need for new, simple, and effective ways to deliver treatment. Management of SUI without face-to-face contact is possible, and Internet-based treatment is a new, promising treatment alternative.ObjectiveTo compare two treatment programmes for stress urinary incontinence (SUI) without face-to-face contact: one Internet-based and one sent by post.Patients and methodsRandomised, controlled trial conducted in Sweden 2009-2011. Computer-generated block-randomisation, allocation by independent administrator. No 'blinding'. The study included 250 community-dwelling women aged 18-70 years, with SUI ≥1 time/week. Consecutive online recruitment. The women had 3 months of either; (i) An Internet-based treatment programme (124 women), including e-mail support and cognitive behavioural therapy assignments or (ii) A treatment programme sent by post (126). Both programmes focused mainly on pelvic floor muscle training.Primary outcomessymptom-score (International Consultation on Incontinence Questionnaire Short Form, ICIQ-UI SF) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life, ICIQ-LUTSQoL).Secondary outcomes(i) Patient Global Impression of Improvement, (ii) Incontinence aids, (iii) Patient satisfaction, (iv) Health-specific QoL (EQ5D-Visual Analogue Scale), and (v) Incontinence episode frequency. Follow-up after 4 months via self-assessed postal questionnaires.ResultsIn all, 12% (30 women) were lost to follow-up. Intention-to-treat analysis showed highly significant improvements (P < 0.001) with large effect sizes (>0.8) with both interventions, but there were no significant differences between groups in primary outcomes. The mean (sd) changes in symptom-score were: Internet 3.4 (3.4), Postal 2.9 (3.1) (P = 0.27). The mean (sd) changes in condition-specific QoL were: Internet 4.8 (6.1), Postal 4.6 (6.7) (P = 0.52). Compared with the postal-group, more participants in the Internet-group perceived they were much or very much improved (40.9% (43/105) vs 26.5% (30/113), P = 0.01), reported reduced usage of incontinence aids (59.5% (47/79) vs 41.4% (34/82), P = 0.02) and were satisfied with the treatment programme (84.8% (89/105) vs 62.9% (71/113), P < 0.001). Health-specific QoL improved in the Internet-group (mean change 3.7 (10.9), P = 0.001), but not in the postal-group (1.9 (13.0), P = 0.13). Overall, 69.8% (120/172) of participants reported complete lack of leakage or reduced number of leakage episodes by >50%.ConclusionsConcerning primary outcomes, treatment effects were similar between groups whereas for secondary outcomes the Internet-based treatment was more effective. Internet-based treatment for SUI is a new, promising treatment alternative.

Dataset Information

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

Introduction and hypothesis

Methods

Results

Discussion

Publications

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

Similar Datasets

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