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

Campbell, K. Gillian; Batt, Mark E.; Drummond, Avril

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

Citation

Campbell, K. G., Batt, M. E., & Drummond, A. (2020). A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study. Pilot and Feasibility Studies, 6, Article 103. https://doi.org/10.1186/s40814-020-00638-6

• Journal Article Type: Article
• Acceptance Date: Jun 18, 2020
• Online Publication Date: Jul 16, 2020
• Publication Date: Jul 16, 2020
• Deposit Date: Jul 13, 2020
• Publicly Available Date: Jul 17, 2020
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Article Number: 103
• DOI: https://doi.org/10.1186/s40814-020-00638-6
• Keywords: Urinary incontinence; Pelvic floor muscle training; Athletes; Physiotherapy
• Public URL: https://nottingham-repository.worktribe.com/output/4765864
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00638-6
• Additional Information: Received: 17 December 2019; Accepted: 26 June 2020; First Online: 16 July 2020; : The study has been reviewed and approved by the University of Nottingham, Faculty of Medicine and Health Sciences Research Ethics Committee (Ethics reference number 280-1904). All participants in all three phases will provide written, informed consent prior to any data collection.; : Not applicable.; : The authors declare that they have no competing interests.