Physiotherapy to Treat Urinary Incontinence in Athletes

NCT03986411 | Completed

• 1 other identifier: A2RMUR
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; pelvic floor; athlete

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Ease of recruiting participants directly from gyms and sports clubs

  Up to 8 Months

• Attrition rate

  The number of participants who consent to participate that remain in the study

  6 months after the participant's first assessment

• Acceptability of the intervention: % that give positive feedback from the interviews

  Measured as the % that give positive feedback from the interviews in Phase 3

  Up to 9 months

• Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews

  Measured as the % positive feedback for each outcome measure from the interviews in Phase 3

  Up to 9 months

• Timescale required for intervention

  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

  Six months for each participant from the first assessment

Secondary Outcomes (2)

• Urinary Distress Inventory (UDI) 6

  Six months from the first assessment for each participant

• International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)

  Six months from the first assessment for each participant

Study Arms (1)

Feasibility study of physiotherapy for UI in athletic women

OTHER

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; Other: Phase 2: Physiotherapy for urinary incontinence; Other: Phase 3: Qualitative Interviews: Participants

Interventions

Phase 1: Qualitative interviews: Health care professionals OTHER

Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community

Feasibility study of physiotherapy for UI in athletic women

Phase 2: Physiotherapy for urinary incontinence OTHER

Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence

Feasibility study of physiotherapy for UI in athletic women

Phase 3: Qualitative Interviews: Participants OTHER

Semi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention

Feasibility study of physiotherapy for UI in athletic women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1: Qualified local Health Care Professional eg G.P., nurse or chartered physiotherapist working within Nottinghamshire or Derbyshire
• 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

You may not qualify if:

• Phase 1: Unwilling or unable to provide written informed consent Not within Nottinghamshire or Derbyshire area
• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35101711 DERIVED

• 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.

  PMID: 32695435 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gillian Campbell, BVMS BSc PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods feasibility study. Three phases: Phase 1: Interviews Health car professionals, Phase 2: Intervention, Phase 3: Interviews of Participants

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: August 27, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: June 1, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 31/01/2021 for up to 5 years
• Access Criteria: By direct contact to the study PI

Locations

GB (1)