Skip to main content
OpenTrials
Completed

NCT Number: NCT03296462

Hip External Rotation Physical Therapy Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lois Hole Hospital for Women, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip external rotation exercise

Other

Standardised HER exercise training by physiotherapist (plus video recording of exercises)

Pelvic floor muscle exercise

Other

Standardised PFM exercise training by physiotherapist (plus video recording of exercises)

Primary outcomes

  1. Feasibility: achieve recruitment of 30 women over 12 months

    Time frame: 12 months

    Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months

  2. Feasibility: achieve follow-up for 60% of recruits over 12 months

    Time frame: 12 months

    Is follow-up complete for 60% of recruits?

Secondary outcomes

  1. Pelvic floor muscle strength

    Time frame: 12 & 24 weeks

    Strength will be measured using Peritron perineometer

  2. External hip rotator muscle strength

    Time frame: 12 & 24 weeks

    Strength will be measured using Microfit ET3

  3. Diary-reported urinary incontinence

    Time frame: 12 & 24 weeks

    3-day bladder diary to record amount and reason for leakage

  4. Incontinence-related quality of life (distress)

    Time frame: 12 & 24 weeks

    UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)

  5. Incontinence-related quality of life (impact)

    Time frame: 12 & 24 weeks

    IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)

  6. Patient mobility (walking)

    Time frame: 12 & 24 weeks

    Six minute walk test - distance walked (metres)

  7. Patient mobility

    Time frame: 12 & 24 weeks

    "timed up and go" test - time in sconds

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Physiotherapy Alberta - College + Association

Registry information

Official study 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

Acronym: HER-Physio

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2017
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.