Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, exercise, pelvic floor muscles, biofeedback, rehabilitative ultrasound imaging
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.
Interventions
OTHERPelvic floor exercises with biofeedback
Exercises will be performed with assistance of biofeedback cueing
Exercises will b performed with verbal cueing of investigator.
Sponsors
Texas Woman's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed