Hip External Rotation Physical Therapy Trial (HER-Physio)

University of Alberta

Status: Completed

Conditions: Urinary Incontinence, Stress

Treatments: Other: Hip external rotation exercise; Other: Pelvic floor muscle exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03296462

Pro00066652

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 3 patient groups

Hip external rotation exercise (alone)

Experimental group

Description:

Standardised hip external rotation exercise training - over 12 week period

Treatment:

Other: Hip external rotation exercise

Hip external rotation + PFM exercises

Experimental group

Description:

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

Treatment:

Other: Hip external rotation exercise

Other: Pelvic floor muscle exercise

pelvic floor muscle exercises (alone)

Active Comparator group

Description:

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

Treatment:

Other: Pelvic floor muscle exercise