Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence. The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback. All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.

Detailed Description
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This study has been terminated.

Official Title
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Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: Pelvic floor exercises with biofeedback
* Other: Pelvic floor muscle exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women will need to be 20 years or older diagnosed with stress urinary incontinence (SUI). Exclusion Criteria: women with: urge or mixed incontinence pelvic organ prolapse previous surgical treatment for incontinence current treatment for SUI (including medications) current pregnancy six months or less postpartum body mass index of ≥ 30 recurrent vulvovaginitis current/recurrent urinary tract infections (UTI) non-English speaking.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic floor muscle exercises<br>Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor. | Other: Pelvic floor muscle exercises<br>* Exercises will b performed with verbal cueing of investigator.<br>|
| Experimental: Pelvic floor exercises with biofeedback<br>Pelvic floor exercises will be performed with biobeedback cueing. | Other: Pelvic floor exercises with biofeedback<br>* Exercises will be performed with assistance of biofeedback cueing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study | Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine. | baseline, 4 weeks, and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study | Incidence of incontinent episodes will be measured using a 7-day bladder diary | Baseline, 4 weeks, and 8 weeks | 
| Change in quality of life from the baseline to the midpoint and completion of the study | Quality of life will be measured using the I-QOL questionnaire | Baseline, 4 weeks, and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging