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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337193 on ClinicalTrials.gov