Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT01337193|
Recruitment Status : Terminated (Principal investigator has decided not to continue her PhD studies.)
First Posted : April 18, 2011
Last Update Posted : November 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Other: Pelvic floor exercises with biofeedback Other: Pelvic floor muscle exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||February 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: Pelvic floor muscle exercises
Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.
Other: Pelvic floor muscle exercises
Exercises will b performed with verbal cueing of investigator.
Experimental: Pelvic floor exercises with biofeedback
Pelvic floor exercises will be performed with biobeedback cueing.
Other: Pelvic floor exercises with biofeedback
Exercises will be performed with assistance of biofeedback cueing
- 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.
- Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study [ Time Frame: Baseline, 4 weeks, and 8 weeks ]Incidence of incontinent episodes will be measured using a 7-day bladder diary
- Change in quality of life from the baseline to the midpoint and completion of the study [ Time Frame: Baseline, 4 weeks, and 8 weeks ]Quality of life will be measured using the I-QOL questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337193
|United States, Texas|
|Texas Woman's University|
|Dallas, Texas, United States, 75235|
|Study Chair:||Elaine Trudell-Jackson, PT, PhD||Texas Woman's University|