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

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence
• Interventions: Other: Pelvic floor exercises with biofeedback; Other: Pelvic floor muscle exercises

• Registration Number: NCT01337193
• Lead Sponsor: Texas Woman's University

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor exercises with biofeedback	Pelvic floor exercises with biofeedback	Pelvic floor exercises will be performed with biobeedback cueing.
Pelvic floor muscle exercises	Pelvic floor muscle exercises	Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Dallas, Texas, United States