Physiotherapy to Treat Urinary Incontinence in Athletes (POsITIve)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Phase 1: Qualitative interviews: Health care professionals
Phase 2: Physiotherapy for urinary incontinence
Phase 3: Qualitative Interviews: Participants
Sponsored by
About this trial
This is an interventional health services research trial for Urinary Incontinence focused on measuring urinary incontinence, pelvic floor, athlete
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
Sites / Locations
- University of Nottingham
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Feasibility study of physiotherapy for UI in athletic women
Arm Description
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
Outcomes
Primary Outcome Measures
Recruitment rate
Ease of recruiting participants directly from gyms and sports clubs
Attrition rate
The number of participants who consent to participate that remain in the study
Acceptability of the intervention: % that give positive feedback from the interviews
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
Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
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
Secondary Outcome Measures
Urinary Distress Inventory (UDI) 6
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03986411
Brief Title
Physiotherapy to Treat Urinary Incontinence in Athletes
Acronym
POsITIve
Official Title
Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, pelvic floor, athlete
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feasibility study of physiotherapy for UI in athletic women
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Phase 1: Qualitative interviews: Health care professionals
Intervention Description
Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
Intervention Type
Other
Intervention Name(s)
Phase 2: Physiotherapy for urinary incontinence
Intervention Description
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
Intervention Type
Other
Intervention Name(s)
Phase 3: Qualitative Interviews: Participants
Intervention Description
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 Measure Information:
Title
Recruitment rate
Description
Ease of recruiting participants directly from gyms and sports clubs
Time Frame
Up to 8 Months
Title
Attrition rate
Description
The number of participants who consent to participate that remain in the study
Time Frame
6 months after the participant's first assessment
Title
Acceptability of the intervention: % that give positive feedback from the interviews
Description
Measured as the % that give positive feedback from the interviews in Phase 3
Time Frame
Up to 9 months
Title
Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews
Description
Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
Time Frame
Up to 9 months
Title
Timescale required for intervention
Description
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
Time Frame
Six months for each participant from the first assessment
Secondary Outcome Measure Information:
Title
Urinary Distress Inventory (UDI) 6
Description
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
Time Frame
Six months from the first assessment for each participant
Title
International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)
Description
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
Time Frame
Six months from the first assessment for each participant
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian Campbell, BVMS BSc PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data may be made available to other researchers at the end of the study
IPD Sharing Time Frame
31/01/2021 for up to 5 years
IPD Sharing Access Criteria
By direct contact to the study PI
Citations:
PubMed Identifier
35101711
Citation
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.
Results Reference
derived
PubMed Identifier
32695435
Citation
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.
Results Reference
derived
Learn more about this trial
Physiotherapy to Treat Urinary Incontinence in Athletes
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