Hip External Rotation Physical Therapy Trial

NCT ID: NCT03296462

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-03
• Study Completion Date: 2019-07-10

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hip external rotation exercise (alone)

Standardised hip external rotation exercise training - over 12 week period

Group Type: EXPERIMENTAL

Hip external rotation exercise

Intervention Type: OTHER

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

Hip external rotation + PFM exercises

Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period

Group Type: EXPERIMENTAL

Hip external rotation exercise

Intervention Type: OTHER

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

Pelvic floor muscle exercise

Intervention Type: OTHER

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

pelvic floor muscle exercises (alone)

Standardised pelvic floor muscle exercises - over 12 week period (usual care)

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle exercise

Intervention Type: OTHER

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

Interventions

Hip external rotation exercise

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

Intervention Type: OTHER

Pelvic floor muscle exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Physiotherapy Alberta - College + Association

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue Ross, PhD

Role: STUDY_DIRECTOR

University of Alberta

Locations

Lois Hole Hospital for Women, Royal Alexandra Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

Pro00066652

Identifier Type: -

Identifier Source: org_study_id