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Clinical Trials/NCT03986411
NCT03986411
Completed
Not Applicable

Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study

University of Nottingham1 site in 1 country19 target enrollmentAugust 27, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University of Nottingham
Enrollment
19
Locations
1
Primary Endpoint
Recruitment rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 27, 2019
End Date
December 3, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: Up to 8 Months

Ease of recruiting participants directly from gyms and sports clubs

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

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

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

Secondary Outcomes

  • 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 Sites (1)

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