Functional Assessment and Muscle Evaluation Through Exercise Trial
Purpose
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.
Condition
- Urinary Incontinence
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Women ≥ 65 years older 2. Symptomatic UI 3. Symptoms ≥ 3 months 4. Episodes of UI on 3-day bladder diary 5. Stress, urgency, and mixed UI
Exclusion Criteria
- Women unable to have functional assessment and/or complete bladder diary 2. Impaired mental status (MMSE <25) 3. Post-void residual ≥ 150 ml 4. Non-ambulatory (wheelchair bound), unable to complete mobility assessments 5. Hematuria 6. Urinary tract infection 7. Continuous Incontinence 8. Pelvic Organ prolapse > stage 2 9. Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test) 10. Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis) 11. Women with contraindications to undergo MRI including claustrophobia.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Multi-modal rehabilitation program |
12 weeks of various exercises |
|
|
Active Comparator Pelvic Floor Physical therapy |
12 weeks of standard pelvic floor physical therapy |
|
Recruiting Locations
Washington, District of Columbia 20060
More Details
- Status
- Unknown status
- Sponsor
- Howard University
Detailed Description
This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence. The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women. The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.