Clinical trial NCT03296462: Hip External Rotation Physical Therapy Trial
Official title: Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Physiotherapy Alberta - College + Association
First posted: 2017-09-28
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: achieve recruitment of 30 women over 12 months
timeFrame: 12 months
measure: Feasibility: achieve follow-up for 60% of recruits over 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: 12 & 24 weeks
measure: External hip rotator muscle strength
timeFrame: 12 & 24 weeks
measure: Diary-reported urinary incontinence
timeFrame: 12 & 24 weeks
measure: Incontinence-related quality of life (distress)
timeFrame: 12 & 24 weeks
measure: Incontinence-related quality of life (impact)
timeFrame: 12 & 24 weeks
measure: Patient mobility (walking)
timeFrame: 12 & 24 weeks
measure: Patient mobility
timeFrame: 12 & 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Lois Hole Hospital for Women, Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sue Ross, PhD
role: STUDY_DIRECTOR
References: