Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Texas Woman's University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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
This study has been terminated.
Investigators
Elaine Trudelle-Jackson
PhD Advisor
Texas Woman's University
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
Time Frame: baseline, 4 weeks, and 8 weeks
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.
Secondary Outcomes
- Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study(Baseline, 4 weeks, and 8 weeks)
- Change in quality of life from the baseline to the midpoint and completion of the study(Baseline, 4 weeks, and 8 weeks)