Functional Assessment and Muscle Evaluation Through Exercise Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Multi-modal rehabilitation program
* Other: Pelvic Floor Physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ≥ 65 years older Symptomatic UI Symptoms ≥ 3 months Episodes of UI on 3-day bladder diary Stress, urgency, and mixed UI Exclusion Criteria: Women unable to have functional assessment and/or complete bladder diary Impaired mental status (MMSE <25) Post-void residual ≥ 150 ml Non-ambulatory (wheelchair bound), unable to complete mobility assessments Hematuria Urinary tract infection Continuous Incontinence Pelvic Organ prolapse > stage 2 Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test) Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis) Women with contraindications to undergo MRI including claustrophobia.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-modal rehabilitation program<br>12 weeks of various exercises | Other: Multi-modal rehabilitation program<br>* Patients will receive 12 weeks of exercises.<br>|
| Active Comparator: Pelvic Floor Physical therapy<br>12 weeks of standard pelvic floor physical therapy | Other: Pelvic Floor Physical therapy<br>* Pelvic Floor Physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | functional assessment | 12 weeks | 
| muscle quality | MRI evaluation | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Pelvic Floor Disorder, Pelvic Floor Muscle, Strength, Disability, Aging, Atrophy, Exercise, Magnetic Resonance Imaging, Fatty Infiltration, Physical Therapy, Multi-modal Rehabilitation, Stress Urinary Incontinence, Urge Urinary Incontinence, Mixed Urinary Incontinence