Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

Sponsor

Texas Woman's University (Other)

Overall Status

Terminated

CT.gov ID

NCT01337193

Collaborator

(none)

Enrollment

Location

Arms

38.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Other: Pelvic floor exercises with biofeedback Other: Pelvic floor muscle exercises	N/A

Detailed Description

This study has been terminated.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Feb 1, 2011

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study [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 Outcome Measures

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]
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 [Baseline, 4 weeks, and 8 weeks]
Quality of life will be measured using the I-QOL questionnaire