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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01337193
• Other study ID #: SUI 16333
• Status: Terminated
• Phase: N/A
• First received: April 1, 2011
• Last updated: November 13, 2014
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study has been terminated.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Pelvic floor exercises with biofeedback
Exercises will be performed with assistance of biofeedback cueing
• Pelvic floor muscle exercises
Exercises will b performed with verbal cueing of investigator.

Locations

Country	Name	City	State
United States	Texas Woman's University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study	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.	baseline, 4 weeks, and 8 weeks	No
Secondary	Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study	Incidence of incontinent episodes will be measured using a 7-day bladder diary	Baseline, 4 weeks, and 8 weeks	No
Secondary	Change in quality of life from the baseline to the midpoint and completion of the study	Quality of life will be measured using the I-QOL questionnaire	Baseline, 4 weeks, and 8 weeks	No