Clinical trial NCT03166150: Functional Assessment and Muscle Evaluation Through Exercise Trial
Official title: Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: 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
Lead sponsor: Howard University
Sponsor class: OTHER
Collaborators: name: National Hispanic Council on Aging (NHCOA)
First posted: 2017-05-25
Enrollment: 18
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of UI episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: muscle strength
timeFrame: 12 weeks
measure: muscle quality
timeFrame: 12 weeks
Other outcomes:
Locations:
city: District of Columbia
country: United States
facility: Howard University Hospital
state: District of Columbia
Study officials:
affiliation: Howard University
name: Tatiana Sanses, M.D.
role: PRINCIPAL_INVESTIGATOR
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