Physiotherapy to Treat Urinary Incontinence in Athletes (POsITIve)
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|ClinicalTrials.gov Identifier: NCT03986411|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : September 10, 2019
Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes.
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Other: Phase 1: Qualitative interviews: Health care professionals Other: Phase 2: Physiotherapy for urinary incontinence Other: Phase 3: Qualitative Interviews: Participants||Not Applicable|
Aims: The investigator's overall purpose is to conduct an RCT to determine whether one to one physiotherapy can improve the symptoms of urinary incontinence (UI) in a group of athletic women. This feasibility study will enable us to ascertain the viability of conducting a definitive appropriately powered trial.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Mixed methods feasibility study. Three phases: Phase 1: Interviews Health car professionals, Phase 2: Intervention, Phase 3: Interviews of Participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study|
|Actual Study Start Date :||August 27, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
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
Other: Phase 1: Qualitative interviews: Health care professionals
Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
Other: Phase 2: Physiotherapy for urinary incontinence
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
Other: 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
- Recruitment rate [ Time Frame: Up to 8 Months ]Ease of recruiting participants directly from gyms and sports clubs
- Attrition rate [ Time Frame: 6 months after the participant's first assessment ]The number of participants who consent to participate that remain in the study
- Acceptability of the intervention: % that give positive feedback from the interviews [ Time Frame: Up to 9 months ]Measured as the % that give positive feedback from the interviews in Phase 3
- Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews [ Time Frame: Up to 9 months ]Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
- Timescale required for intervention [ Time Frame: Six months for each participant from the first assessment ]The time required for a successful intervention. This will be measured by the change in the secondary outcome measures between the three month assessment and the six months assessment
- Urinary Distress Inventory (UDI) 6 [ Time Frame: Six months from the first assessment for each participant ]A short questionnaire to evaluate 'bother' of urinary symptoms (6 questions) mean score x 33.3 to give a final score out of 100. Where 100 indicates the most severe urinary distress
- International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF) [ Time Frame: Six months from the first assessment for each participant ]A long quality of life and descriptive questionnaire to establish type and severity of urinary symptoms and the impact of these on quality of life (Two scores: urinary symptoms max score 69 where this is indicates the most severe; quality of life score, where the maximum score is 150, where urinary symptoms are having the maximum negative impact on quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986411
|Contact: Gillian Campbell, BVMS BSc PhD||+44 (0) 115 823 email@example.com|
|Contact: Avril E Drummond, MSc PhD||+44 (0)115 823 firstname.lastname@example.org|
|University of Nottingham||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Principal Investigator:||Gillian Campbell, BVMS BSc PhD||University of Nottingham|