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Completed

NCT Number: NCT03986411

Physiotherapy to Treat Urinary Incontinence in Athletes

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Phase 2: Physiotherapy for urinary incontinence

Other

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

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

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 8 Months

    Ease of recruiting participants directly from gyms and sports clubs

  2. 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

  3. 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

  4. 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

  5. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: POsITIve

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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