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Physiotherapy to Treat Urinary Incontinence in Athletes (POsITIve)

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ClinicalTrials.gov Identifier: NCT03986411
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.


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

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.


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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
Estimated Study Start Date : June 14, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986411


Contacts
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Contact: Gillian Campbell, BVMS BSc PhD +44 (0) 115 823 0116 gillian.campbell@nottingham.ac.uk
Contact: Avril E Drummond, MSc PhD +44 (0)115 823 0493 avril.drummond@nottingham.ac.uk

Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Gillian Campbell, BVMS BSc PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03986411     History of Changes
Other Study ID Numbers: A2RMUR
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data may be made available to other researchers at the end of the study
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 31/01/2021 for up to 5 years
Access Criteria: By direct contact to the study PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Nottingham:
urinary incontinence
pelvic floor
athlete

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders