Hip External Rotation Physical Therapy Trial

Urinary Incontinence, Stress Clinical Trial

— HER-Physio  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296462
• Other study ID #: Pro00066652
• Status: Completed
• Phase: N/A
• Start date: November 3, 2016
• Est. completion date: July 10, 2019

Study information

• Verified date: May 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Hip external rotation exercise
Standardised HER exercise training by physiotherapist (plus video recording of exercises)
• Pelvic floor muscle exercise
Standardised PFM exercise training by physiotherapist (plus video recording of exercises)

Locations

Country	Name	City	State
Canada	Lois Hole Hospital for Women, Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Physiotherapy Alberta - College + Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility: achieve follow-up for 60% of recruits over 12 months	Is follow-up complete for 60% of recruits?	12 months
Secondary	Pelvic floor muscle strength	Strength will be measured using Peritron perineometer	12 & 24 weeks
Secondary	External hip rotator muscle strength	Strength will be measured using Microfit ET3	12 & 24 weeks
Secondary	Diary-reported urinary incontinence	3-day bladder diary to record amount and reason for leakage	12 & 24 weeks
Secondary	Incontinence-related quality of life (distress)	UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)	12 & 24 weeks
Secondary	Incontinence-related quality of life (impact)	IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)	12 & 24 weeks
Secondary	Patient mobility (walking)	Six minute walk test - distance walked (metres)	12 & 24 weeks
Secondary	Patient mobility	"timed up and go" test - time in sconds	12 & 24 weeks