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

  1. 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

  1. 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

ArmDescriptionAssigned Intervention
Experimental
Multi-modal rehabilitation program
12 weeks of various exercises
  • Other: Multi-modal rehabilitation program
    Patients will receive 12 weeks of exercises.
Active Comparator
Pelvic Floor Physical therapy
12 weeks of standard pelvic floor physical therapy
  • Other: Pelvic Floor Physical therapy
    Pelvic Floor Physical therapy

Recruiting Locations

Howard University Hospital
Washington, District of Columbia 20060
Contact:
Tatiana Sanses, MD
202-865-1164
tatiana.sanses@howard.edu

More Details

Status
Unknown status
Sponsor
Howard University

Study Contact

Tatiana V Sanses, M.D.
2028651164
tatiana.sanses@howard.edu

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.