Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Principal investigator has decided not to continue her PhD studies.)
Information provided by (Responsible Party):
Elaine Trudelle-Jackson, Texas Woman's University Identifier:
First received: April 1, 2011
Last updated: November 13, 2014
Last verified: November 2014

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 exercises with biofeedback
Other: Pelvic floor muscle exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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:

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 ]
    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 ]
    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 ]
    Quality of life will be measured using the I-QOL questionnaire

Enrollment: 28
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This study has been terminated.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01337193

United States, Texas
Texas Woman's University
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Texas Woman's University
Study Chair: Elaine Trudell-Jackson, PT, PhD Texas Woman's University
  More Information

Responsible Party: Elaine Trudelle-Jackson, PhD Advisor, Texas Woman's University Identifier: NCT01337193     History of Changes
Other Study ID Numbers: SUI 16333
Study First Received: April 1, 2011
Last Updated: November 13, 2014

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders processed this record on May 23, 2017