Dataset Information

Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

ABSTRACT: 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.

SUBMITTER: Hagovska M

PROVIDER: S-EPMC7015553 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

Hagovska Magdalena M Svihra Jan J

Medicine 20200201 6

<h4>Introduction</h4>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 ...[more]

PMID: 32028393

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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: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

Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

Publications

Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

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