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运动女性尿失禁物理治疗管理的可行性研究:积极研究的试验方案

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

作者信息

Campbell K Gillian, Batt Mark E, Drummond Avril

机构信息

Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, NG7 2HA UK.

Centre for Sports Medicine, Nottingham University Hospitals, Nottingham, UK.

出版信息

Pilot Feasibility Stud. 2020 Jul 16;6:103. doi: 10.1186/s40814-020-00638-6. eCollection 2020.

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.

摘要

背景

在英国,高达40%的成年女性受尿失禁(UI)影响,盆底肌训练可作为一种有效的治疗方法。运动女性中尿失禁的患病率高于久坐不动的女性,但针对此现象的原因或该人群的治疗方法研究较少。本研究的目的是探讨未来对运动女性尿失禁进行物理治疗管理的随机对照试验的可行性。

方法

这是一项混合方法研究,包括三个不同但相关的阶段。

第一阶段

对社区医疗保健专业人员进行半结构化访谈,以探索女性尤其是女运动员尿失禁的当前管理实践,为未来研究的对照组提供信息。这还将确定社区医疗保健专业人员对盆底健康物理治疗的理解。

第二阶段

直接从健身房和体育俱乐部招募的运动女性和经常锻炼的女性将接受一个疗程的物理治疗以管理尿失禁。这将确定研究的招募、合格性、同意、出勤、损耗和数据完成率。它将提供有关适合该患者群体的临床场所和结局指标的信息。

第三阶段

对从第二阶段中有目的地选择的参与者进行半结构化访谈,以调查参与者对招募程序、干预措施、结局指标和场所的满意度。此外,我们将收集有关使用智能手机“应用程序”进行家庭锻炼依从性和监测的数据,以及参与者对未来研究中随机分组的看法。我们将更详细地探讨尿失禁对生活和运动的影响。

讨论

本研究将确定直接从健身房和体育俱乐部招募运动女性的难易程度和可接受性,并确定损耗率。它还将探索干预措施、临床场所和结局指标的可接受性。收集到的数据将用于为未来的随机对照试验提供信息。

试验注册

NCT03986411(clinicaltrials.gov)。于2019年6月14日注册。

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