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A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study.

ABSTRACT: Background:Urinary incontinence (UI) affects up to 40% of adult women within the UK, and pelvic floor muscle training can be effective as a treatment. The prevalence of UI is higher in athletic women than in their sedentary counterparts, but there is little research into reasons for this or into treatment within this population.The aim of this study is to investigate the feasibility of conducting a future randomised controlled trial of physiotherapeutic management of UI in athletic women. Methods:This is a mixed methods study with three distinct but related phases.Phase 1: Semi-structured interviews with health care professionals in the community will explore current management practices of UI in women and particularly in female athletes in order to inform the control arm of a future study. It will also establish community health care professionals' understanding of pelvic health physiotherapy.Phase 2: Athletic and regularly exercising women recruited directly from gyms and sports clubs will undergo a course of physiotherapy to manage UI. This will establish study recruitment, eligibility, consent, attendance, attrition, and data completion rates. It will provide information regarding appropriate clinical venues and outcome measures to use for this patient group.Phase 3: Semi-structured interviews with purposefully selected participants from phase 2 will investigate participant satisfaction with recruitment procedures, the intervention, outcome measures and the venues. Further, we will collect data regarding the use of a smartphone 'app' for adherence and monitoring of home exercises and participants' beliefs around randomisation in a future study. We will explore the impact of UI on life and sport in more detail. Discussion:This study will establish the ease and acceptability of recruiting athletic women directly from gyms and sports clubs and identify attrition rates. It will also explore the acceptability of the intervention, clinical venues and outcome measures. Data collected will be used to inform a future randomised controlled trial. Trial registration:NCT03986411 (clinicaltrials.gov). Registered on 14 June 2019.

SUBMITTER: Campbell KG

PROVIDER: S-EPMC7366300 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study.

Campbell K Gillian KG Batt Mark E ME Drummond Avril A

Pilot and feasibility studies 20200716

<h4>Background</h4>Urinary incontinence (UI) affects up to 40% of adult women within the UK, and pelvic floor muscle training can be effective as a treatment. The prevalence of UI is higher in athletic women than in their sedentary counterparts, but there is little research into reasons for this or into treatment within this population.The aim of this study is to investigate the feasibility of conducting a future randomised controlled trial of physiotherapeutic management of UI in athletic women ...[more]

PMID: 32695435

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Project description:Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT.The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages.Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice.ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

Project description:IntroductionRectal cancer affects more than 600 patients per year in Wales, with a 5-year survival rate of around 60%. A recent report demonstrated that 19% of patients with bowel cancer had difficulty controlling their bowels after surgery, and these patients were twice as likely to report lower quality of life than those who had control. Nearly all patients will experience bowel dysfunction initially following surgery and up to 25% will experience severe bowel dysfunction on a long-term basis. The aim of this study is to test the feasibility of introducing a simple intervention in an attempt to improve bowel function following surgery for rectal cancer. We propose the introduction of an educational session from specialist nurses and physiotherapists prior to surgery and a subsequent physiotherapy programme for 3 months to teach patients how to strengthen their pelvic floor.Methods and analysisAll patients with rectal cancer planned to receive an anterior resection will be approached for the study. The study will take place in three centres over 12 months, and we expect to recruit 40 patients. The primary outcome measure is the proportion of eligible patients approached who consent to and attend the educational session. The secondary outcomes include patient compliance to the pelvic floor rehabilitation programme (assessed by patient paper or electronic diary), the acceptability of the intervention to the patient (assessed using qualitative interviews) and preoperative and postoperative pelvic floor tone (assessed using the Oxford Grading System and the International Continence Society Grading System), patient bowel function and patient quality of life (assessed using validated questionnaires).Ethics and disseminationEthics approval was granted. This feasibility study is in progress. If patients find the intervention acceptable, the next stage would be a trial comparing outcomes after anterior resection in those who have and do not have physiotherapy.Trial registration numberISRCTN77383505; Pre-results.

Project description:PurposeUrinary incontinence and fecal incontinence are common disorders in women that negatively impact quality of life. In addition to known health and lifestyle risk factors, genetics may have a role in continence. Identification of genetic variants associated with urinary incontinence and fecal incontinence could result in a better understanding of etiologic pathways, and new interventions and treatments.Materials and methodsWe previously generated genome-wide single nucleotide polymorphism data from Nurses' Health Studies participants. The participants provided longitudinal urinary incontinence and fecal incontinence information via questionnaires. Cases of urinary incontinence (6,120) had at least weekly urinary incontinence reported on a majority of questionnaires (3 or 4 across 12 to 16 years) while controls (4,811) consistently had little to no urinary incontinence reported. We classified cases of urinary incontinence in women into stress (1,809), urgency (1,942) and mixed (2,036) subtypes. Cases of fecal incontinence (4,247) had at least monthly fecal incontinence reported on a majority of questionnaires while controls (11,634) consistently had no fecal incontinence reported. We performed a genome-wide association study for each incontinence outcome.ResultsWe identified 8 single nucleotide polymorphisms significantly associated (p <5×10-8) with urinary incontinence located in 2 loci, chromosomes 8q23.3 and 1p32.2. There were no genome-wide significant findings for the urinary incontinence subtype analyses. However, the significant associations for overall urinary incontinence were stronger for the urgency and mixed subtypes than for stress. While no single nucleotide polymorphism reached genome-wide significance for fecal incontinence, 4 single nucleotide polymorphisms had p <10-6.ConclusionsFew studies have collected genetic data and detailed urinary incontinence and fecal incontinence information. This genome-wide association study provides initial evidence of genetic associations for urinary incontinence and merits further research to replicate our findings and identify additional risk variants.

Dataset Information

A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study.

Publications

A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study.

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