Clinical trial NCT01337193: Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
Official title: Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
exercise
pelvic floor muscles
biofeedback
rehabilitative ultrasound imaging
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. women will need to be 20 years or older
2. diagnosed with stress urinary incontinence (SUI).

Exclusion Criteria:

women with:

1. urge or mixed incontinence
2. pelvic organ prolapse
3. previous surgical treatment for incontinence
4. current treatment for SUI (including medications)
5. current pregnancy
6. six months or less postpartum
7. body mass index of ≥ 30
8. recurrent vulvovaginitis
9. current/recurrent urinary tract infections (UTI)
10. non-English speaking.

Primary outcomes:
measure: Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
timeFrame: baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change in quality of life from the baseline to the midpoint and completion of the study
timeFrame: Baseline, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Elaine Trudell-Jackson, PT, PhD
role: STUDY_CHAIR
References: