Functional Assessment and Muscle Evaluation Through Exercise Trial

NCT03166150 | Completed DMC

• 1 other identifier: 18-MED-21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• muscle strength

  12 weeks

• muscle quality

  12 weeks

Study Arms (2)

Multi-modal rehabilitation program

EXPERIMENTAL

12 weeks of various exercises

Other: Multi-modal rehabilitation program

Pelvic Floor Physical therapy

ACTIVE COMPARATOR

12 weeks of standard pelvic floor physical therapy

Other: Pelvic Floor Physical therapy

Interventions

Multi-modal rehabilitation program OTHER

Patients will receive 12 weeks of exercises.

Multi-modal rehabilitation program

Pelvic Floor Physical therapy OTHER

Pelvic Floor Physical therapy

Pelvic Floor Physical therapy

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Women ≥ 65 years older
• Symptomatic UI
• Symptoms ≥ 3 months
• Episodes of UI on 3-day bladder diary
• Stress, urgency, and mixed UI

You may not qualify if:

• 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.

Sponsors & Collaborators

• Howard University: lead
• National Hispanic Council on Aging (NHCOA): collaborator

Study Sites (1)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders; Atrophy; Motor Activity; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Pathological Conditions, Anatomical; Behavior

Study Officials

• Tatiana Sanses, M.D.

  Howard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACOG FPMRS, Associate Professor, Chief, Female Pelvic Medicine & Reconstructive Surgery, Urogynecology

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: April 25, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: March 24, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)