Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic floor exercises with biofeedback
Pelvic floor muscle exercises
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging
Eligibility Criteria
Inclusion Criteria:
- women will need to be 20 years or older
- diagnosed with stress urinary incontinence (SUI).
Exclusion Criteria:
women with:
- urge or mixed incontinence
- pelvic organ prolapse
- previous surgical treatment for incontinence
- current treatment for SUI (including medications)
- current pregnancy
- six months or less postpartum
- body mass index of ≥ 30
- recurrent vulvovaginitis
- current/recurrent urinary tract infections (UTI)
- non-English speaking.
Sites / Locations
- Texas Woman's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pelvic floor muscle exercises
Pelvic floor exercises with biofeedback
Arm Description
Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.
Pelvic floor exercises will be performed with biobeedback cueing.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT01337193
First Posted
April 1, 2011
Last Updated
November 13, 2014
Sponsor
Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT01337193
Brief Title
Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator has decided not to continue her PhD studies.
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor muscle exercises
Arm Type
Active Comparator
Arm Description
Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.
Arm Title
Pelvic floor exercises with biofeedback
Arm Type
Experimental
Arm Description
Pelvic floor exercises will be performed with biobeedback cueing.
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercises with biofeedback
Intervention Description
Exercises will be performed with assistance of biofeedback cueing
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle exercises
Intervention Description
Exercises will b performed with verbal cueing of investigator.
Primary Outcome Measure Information:
Title
Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study
Description
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.
Time Frame
baseline, 4 weeks, and 8 weeks
Secondary Outcome Measure Information:
Title
Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study
Description
Incidence of incontinent episodes will be measured using a 7-day bladder diary
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change in quality of life from the baseline to the midpoint and completion of the study
Description
Quality of life will be measured using the I-QOL questionnaire
Time Frame
Baseline, 4 weeks, and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women will need to be 20 years or older
diagnosed with stress urinary incontinence (SUI).
Exclusion Criteria:
women with:
urge or mixed incontinence
pelvic organ prolapse
previous surgical treatment for incontinence
current treatment for SUI (including medications)
current pregnancy
six months or less postpartum
body mass index of ≥ 30
recurrent vulvovaginitis
current/recurrent urinary tract infections (UTI)
non-English speaking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Trudell-Jackson, PT, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Study Chair
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
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Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence
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