Functional Assessment and Muscle Evaluation Through Exercise Trial (FAME)

Howard University

Status: Completed

Conditions: Urinary Incontinence

Treatments: Other: Multi-modal rehabilitation program; Other: Pelvic Floor Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03166150

18-MED-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Multi-modal rehabilitation program

Experimental group

Description:

12 weeks of various exercises

Treatment:

Other: Multi-modal rehabilitation program

Pelvic Floor Physical therapy

Active Comparator group

Description:

12 weeks of standard pelvic floor physical therapy

Treatment:

Other: Pelvic Floor Physical therapy