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Completed

NCT Number: NCT03166150

Functional Assessment and Muscle Evaluation Through Exercise Trial

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-modal rehabilitation program

Other

Patients will receive 12 weeks of exercises.

Pelvic Floor Physical therapy

Other

Pelvic Floor Physical therapy

Primary outcomes

  1. Reduction of UI episodes

    Time frame: 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 outcomes

  1. muscle strength

    Time frame: 12 weeks

    functional assessment

  2. muscle quality

    Time frame: 12 weeks

    MRI evaluation

Sponsors and collaborators

Lead sponsor

Howard University

Other

Collaborators

  • National Hispanic Council on Aging (NHCOA)

Registry information

Official study title

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

Acronym: FAME

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 25, 2017
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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