Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
Stopped early · Not applicable
Conditions studied: Stress Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT01337193
- Run by
- Texas Woman's University
- People needed
- 28
- Starts
- 2011-02-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2014-11-14
Who can join
Age: 20 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- women will need to be 20 years or older
- diagnosed with stress urinary incontinence (SUI).
You may not qualify if…
- 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.
Where it is running
- Texas Woman's University — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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