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Trial record 3 of 103 for:    Open Studies | "Urinary Incontinence"
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Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

This study is currently recruiting participants.
Verified June 2012 by Texas Woman's University
Sponsor:
Information provided by (Responsible Party):
Lisa Fleisher, Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01337193
First received: April 1, 2011
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Stress Urinary Incontinence
 Other: Pelvic floor muscle exercises with biofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life will be measured using the I-QOL questionnaire


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic floor muscle exercises
Three pelvic floor muscle exercises will be performed twice a week for 8 weeks with verbal cueing from the instructor.
 Other: Pelvic floor muscle exercises with biofeedback
Three pelvic floor muscle exercises will be performed twice a week for 8 weeks with the use of a transabdominal ultrasound imaging machine being used. The ultrasound head will be placed over the lower abdomen. The participant will be able to see the bladder and the pelvic floor muscles lift when contracted properly. The ultrasound machine will give visual biofeedback to the participant so that they can correctly contract the pelvic floor muscles.
Other Name: Transabdominal ultrasound imaging

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337193

Contacts
Contact: Lisa Fleisher 214 706-2300 fleisher@sbcglobal.net
Contact: Elaine Trudelle-Jackson 214 706-2300 ejackson@twu.edu

Locations
United States, Texas
Texas Woman's University Recruiting
Dallas, Texas, United States, 75225
Contact: Lisa Fleisher     214-706-2300     fleisher@sbcglobal.net    
Principal Investigator: Lisa Fleisher, PhDc            
Sponsors and Collaborators
Texas Woman's University
Investigators
Study Chair: Elaine Trudell-Jackson, Ph.D. Texas Woman's University
  More Information

No publications provided

Responsible Party: Lisa Fleisher, PhD Candidate, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01337193     History of Changes
Other Study ID Numbers: SUI 16333
Study First Received: April 1, 2011
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Woman's University:
stress urinary incontinence
exercise
pelvic floor muscles
biofeedback
rehabilitative ultrasound imaging

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013