Physiotherapy to Treat Urinary Incontinence in Athletes
NCT ID: NCT03986411
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2019-08-27
2020-12-03
Brief Summary
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UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues.
Evidence suggests athletes have stronger pelvic floors than non-athletes. If the pelvic floor is overactive, general advice regarding pelvic floor strengthening will not improve UI, and may make it worse.
This study will explore the feasibility of conducting a larger trial to identify cost effectiveness and benefits of treating athletes with physiotherapy and how this might differ from current practice.
15 -20 athletic women will complete questionnaires regarding their UI and its effects on them. They will receive physiotherapy; the assessment will include a history and internal examination of their pelvic floor. This will inform a tailored rehabilitation program.
Interviews will be conducted with some of these women to explore their response to the intervention. Interviews with health professionals will establish current practice for this patient group.
The results will tell us how likely it is for athletes to volunteer and take part in a future study and which outcomes are useful.
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Detailed Description
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Research protocol: The research design is a mixed methods study with three distinct but related phases.
Phase 1: 6-8 local health care professionals (GPs, nurses and physiotherapists) will be recruited for interview to explore current management practices of urinary incontinence (UI) in primary care.
Phase 2: 15-20 sporting or athletic women who self- report symptoms of UI will be recruited from the local sporting community. Each will undergo individual subjective and objective assessments in order to establish history, symptoms and pelvic floor muscle function. The intervention will be then be tailored from these assessments and agreed between each individual and the specialist physiotherapist. It will include guided exercise within the clinic and a regular home exercise plan, in keeping with typical pelvic health regimes for pelvic floor muscle (PFM) dysfunction.
Phase 3: 6-8 participants from phase 2 will be invited to take part in a qualitative interview in order to gain more in-depth understanding of UI. Purposeful selection will account for age, sporting activity and severity of symptoms. The interviews will be to explore the effects of UI on their quality of life, their participation in sport and exercise and the acceptability of the intervention.
Measurable end points: 6 months from recruitment of the last participant in phase 2 will be considered to be the end point of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Feasibility study of physiotherapy for UI in athletic women
A mixed methods study with 3 distinct but related phases to explore the feasibility of conducting an RCT of physiotherapy as management of urinary incontinence in athletic women
Phase 1: Qualitative interviews: Health care professionals
Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
Phase 2: Physiotherapy for urinary incontinence
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
Phase 3: Qualitative Interviews: Participants
Semi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention
Interventions
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Phase 1: Qualitative interviews: Health care professionals
Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
Phase 2: Physiotherapy for urinary incontinence
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
Phase 3: Qualitative Interviews: Participants
Semi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention
Eligibility Criteria
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Inclusion Criteria
* Phases 2 and 3:Adult female Currently exercising for a minimum 3 times a week and for over 150 minutes per week Self-reported experience of symptoms of UI defined as; leaking of urine associated with increased abdominal pressure e.g. impact, leaking of urine associated with urinary urge, increased urinary urge and/or increased urinary frequency
Exclusion Criteria
* Phases 2 and 3: Under 18 Sports participation less than 1 year Pregnancy Less than one year after childbirth Ongoing physiotherapy or continence advice treatment elsewhere or within the last year De novo oestrogen or anticholinergic treatment Existing neurological conditions that may contribute to UI eg multiple sclerosis, stroke, spinal injury etc Unwilling or unable to provide written informed consent Unable to read or speak English
18 Years
FEMALE
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Gillian Campbell, BVMS BSc PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Campbell KG, Nouri F, E Batt M, Drummond A. Management of urinary incontinence in athletic women: the POsITIve feasibility study. Physiotherapy. 2022 Mar;114:30-37. doi: 10.1016/j.physio.2021.12.001. Epub 2021 Dec 18.
Campbell KG, Batt ME, Drummond A. A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study. Pilot Feasibility Stud. 2020 Jul 16;6:103. doi: 10.1186/s40814-020-00638-6. eCollection 2020.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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A2RMUR
Identifier Type: -
Identifier Source: org_study_id
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