Hip External Rotation Physical Therapy Trial (HER-Physio)

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Other: Hip external rotation exercise; Other: Pelvic floor muscle exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Lois Hole Hospital for Women, Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hip external rotation exercise (alone); Standardised hip external rotation exercise training - over 12 week period	Other: Hip external rotation exercise; Standardised HER exercise training by physiotherapist (plus video recording of exercises)
EXPERIMENTAL: Hip external rotation + PFM exercises; Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period	Other: Hip external rotation exercise; Standardised HER exercise training by physiotherapist (plus video recording of exercises); Other: Pelvic floor muscle exercise; Standardised PFM exercise training by physiotherapist (plus video recording of exercises)
ACTIVE_COMPARATOR: pelvic floor muscle exercises (alone); Standardised pelvic floor muscle exercises - over 12 week period (usual care)	Other: Pelvic floor muscle exercise; Standardised PFM exercise training by physiotherapist (plus video recording of exercises)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Physiotherapy Alberta - College + Association
• Investigators: Study Director: Sue Ross, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2016
• Primary Completion (ACTUAL): July 10, 2019
• Study Completion (ACTUAL): July 10, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (ACTUAL): September 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: Pro00066652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No