Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
NCT01337193 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2014-11-14
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.
Conditions
- Stress Urinary Incontinence
Interventions
- OTHER
-
Pelvic floor exercises with biofeedback
Exercises will be performed with assistance of biofeedback cueing
- OTHER
-
Pelvic floor muscle exercises
Exercises will b performed with verbal cueing of investigator.
Sponsors & Collaborators
-
Texas Woman's University
lead OTHER
Principal Investigators
-
Elaine Trudell-Jackson, PT, PhD · Texas Woman's University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2014-05-31
- Completion
- 2014-05-31
Countries
- United States
Study Locations
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