Functional Assessment and Muscle Evaluation Through Exercise Trial

Urinary Incontinence Clinical Trial

— FAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166150
• Other study ID #: 18-MED-21
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2020
• Source: Howard University
• Contact: Tatiana V Sanses, M.D.
• Phone: 2028651164
• Email: tatiana.sanses[@]howard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Multi-modal rehabilitation program
Patients will receive 12 weeks of exercises.
• Pelvic Floor Physical therapy
Pelvic Floor Physical therapy

Locations

Country	Name	City	State
United States	Howard University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Howard University	National Hispanic Council on Aging (NHCOA)

Country where clinical trial is conducted

United States, 

References & Publications (38)

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Waddie B, Meawad E.

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	muscle strength	functional assessment	12 weeks
Secondary	muscle quality	MRI evaluation	12 weeks