Functional Assessment and Muscle Evaluation Through Exercise Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03166150

Acronym

FAME

Enrollment

Registered

2017-05-25

Start date

2018-04-25

Completion date

2021-05-31

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERMulti-modal rehabilitation program

Patients will receive 12 weeks of exercises.

OTHERPelvic Floor Physical therapy

Pelvic Floor Physical therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
muscle strength	12 weeks	functional assessment
muscle quality	12 weeks	MRI evaluation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026