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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Standardised HER exercise training by physiotherapist (plus video recording of exercises)
Standardised PFM exercise training by physiotherapist (plus video recording of exercises)
Lois Hole Hospital for Women, Royal Alexandra Hospital
Edmonton, Alberta, Canada
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
Time frame: 12 months
Feasibility: achieve follow-up for 60% of recruits over 12 months
Is follow-up complete for 60% of recruits?
Time frame: 12 months
Pelvic floor muscle strength
Strength will be measured using Peritron perineometer
Time frame: 12 & 24 weeks
External hip rotator muscle strength
Strength will be measured using Microfit ET3
Time frame: 12 & 24 weeks
Diary-reported urinary incontinence
3-day bladder diary to record amount and reason for leakage
Time frame: 12 & 24 weeks
Incontinence-related quality of life (distress)
UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)
Time frame: 12 & 24 weeks
Incontinence-related quality of life (impact)
IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)
Time frame: 12 & 24 weeks
Patient mobility (walking)
Six minute walk test - distance walked (metres)
Time frame: 12 & 24 weeks
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Patient mobility
"timed up and go" test - time in sconds
Time frame: 12 & 24 weeks