Functional Assessment and Muscle Evaluation Through Exercise Trial

Howard University18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Incontinence

Interventions

Multi-modal rehabilitation programOTHER

Patients will receive 12 weeks of exercises.

Pelvic Floor Physical therapyOTHER

Pelvic Floor Physical therapy

Eligibility

Sex: FEMALEMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Howard University Hospital

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Reduction of UI episodes

The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.

Time frame: 12 weeks

Secondary Outcomes

muscle strength

functional assessment

Time frame: 12 weeks

muscle quality

MRI evaluation

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.