Hip External Rotation Physical Therapy Trial

Study Overview
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Brief Summary
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This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants. The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.

Detailed Description
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Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (SUI) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (PFM) exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise alone or in combination with PFM is more or less effective than PFM exercises alone. Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants. Interventions: The interventions used in the feasibility study will be training of (1) HER exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI. Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention. Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. The design of the proposed RCT will be based on these feasibility outcomes. Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of life, and (to test patient mobility) six minute walk test and timed up and go test. Sample size: The proposed sample size is 30 participants. Duration of study: After recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at the end of that period, and a further follow up at 24 weeks from recruitment.

Official Title
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Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Other: Hip external rotation exercise
* Other: Pelvic floor muscle exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stress urinary incontinence Attending Lois Hole Hospital for Women Urogynecology Clinic Referred for physiotherapy for stress urinary incontinence Able to toilet independently Able to undertake hip rotation exercises Able to speak and read English Exclusion Criteria: Urge urinary incontinence Using a pessary Neurological or cognitive impairment Using other treatment for incontinence Unable to complete study forms Unable to understand educational instruction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hip external rotation exercise (alone)<br>Standardised hip external rotation exercise training - over 12 week period | Other: Hip external rotation exercise<br>* Standardised HER exercise training by physiotherapist (plus video recording of exercises)<br>|
| Experimental: Hip external rotation + PFM exercises<br>Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period | Other: Hip external rotation exercise<br>* Standardised HER exercise training by physiotherapist (plus video recording of exercises)<br>Other: Pelvic floor muscle exercise<br>* Standardised PFM exercise training by physiotherapist (plus video recording of exercises)<br>|
| Active Comparator: pelvic floor muscle exercises (alone)<br>Standardised pelvic floor muscle exercises - over 12 week period (usual care) | Other: Pelvic floor muscle exercise<br>* Standardised PFM exercise training by physiotherapist (plus video recording of exercises)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: achieve recruitment of 30 women over 12 months | Is recruitment feasible? Feasibility is defined as achieving recruitment target of 30 recruits within 12 months | 12 months | 
| Feasibility: achieve follow-up for 60% of recruits over 12 months | Is follow-up complete for 60% of recruits? | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength | Strength will be measured using Peritron perineometer | 12 & 24 weeks | 
| External hip rotator muscle strength | Strength will be measured using Microfit ET3 | 12 & 24 weeks | 
| Diary-reported urinary incontinence | 3-day bladder diary to record amount and reason for leakage | 12 & 24 weeks | 
| Incontinence-related quality of life (distress) | UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum) | 12 & 24 weeks | 
| Incontinence-related quality of life (impact) | IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum) | 12 & 24 weeks | 
| Patient mobility (walking) | Six minute walk test - distance walked (metres) | 12 & 24 weeks | 
| Patient mobility | timed up and go test - time in sconds | 12 & 24 weeks |