Physiotherapy to Treat Urinary Incontinence in Athletes

Urinary Incontinence Clinical Trial

— POsITIve  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986411
• Other study ID #: A2RMUR
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: December 3, 2020

Study information

• Verified date: November 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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
• Phase 2: Physiotherapy for urinary incontinence
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
• 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

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Ease of recruiting participants directly from gyms and sports clubs	Up to 8 Months
Primary	Attrition rate	The number of participants who consent to participate that remain in the study	6 months after the participant's first assessment
Primary	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
Primary	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
Primary	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	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	Six months from the first assessment for each participant
Secondary	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	Six months from the first assessment for each participant