Functional Assessment and Muscle Evaluation Through Exercise Trial

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: Pelvic Floor Physical therapy; Other: Multi-modal rehabilitation program

• Registration Number: NCT03166150
• Lead Sponsor: Howard University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-25
• Study Start: 2018-04-25
• Status Verified: 2020-09
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Physical therapy	Pelvic Floor Physical therapy	12 weeks of standard pelvic floor physical therapy
Multi-modal rehabilitation program	Multi-modal rehabilitation program	12 weeks of various exercises

Primary Outcome Measures

Name	Time	Method
Reduction of UI episodes	12 weeks	The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.

Secondary Outcome Measures

Name	Time	Method
muscle strength	12 weeks	functional assessment
muscle quality	12 weeks	MRI evaluation

Trial Locations

Locations (1)

Howard University Hospital; 🇺🇸 District of Columbia, District of Columbia, United States