Hip External Rotation Physical Therapy Trial

Not Applicable

Completed

• Conditions: Urinary Incontinence, Stress
• Interventions: Other: Hip external rotation exercise; Other: Pelvic floor muscle exercise

• Registration Number: NCT03296462
• Lead Sponsor: University of Alberta

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11-03
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip external rotation exercise (alone)	Hip external rotation exercise	Standardised hip external rotation exercise training - over 12 week period
pelvic floor muscle exercises (alone)	Pelvic floor muscle exercise	Standardised pelvic floor muscle exercises - over 12 week period (usual care)
Hip external rotation + PFM exercises	Pelvic floor muscle exercise	Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period
Hip external rotation + PFM exercises	Hip external rotation exercise	Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period

Primary Outcome Measures

Name	Time	Method
Feasibility: achieve recruitment of 30 women over 12 months	12 months	Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months
Feasibility: achieve follow-up for 60% of recruits over 12 months	12 months	Is follow-up complete for 60% of recruits?

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lois Hole Hospital for Women, Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada