Muscle and Functional Assessment in Leakage Study (M-FALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03166150
Recruitment Status : Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Tatiana Sanses, Baltimore VA Medical Center

Brief Summary:
The purpose of this study is to improve urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation. The study will also look at quality of pelvic floor and lower extremities muscles using MRI (Magnetic Resonance Imaging).

Condition or disease Intervention/treatment Phase
Urinary Incontinence in Old Age Other: Multi-modal rehabilitation program Other: Pelvic Floor Physical therapy Not Applicable

Detailed Description:

This study will provide data on benefits of combination of multimodal strengthening and aerobic conditioning rehabilitation program with PFMT and will help to characterize changes pelvic floor and lower extremity muscles in older women with UI after multimodal strengthening and aerobic conditioning rehabilitation program with PFMT.

The proposed study will shift the paradigm in the evaluation and treatment of older women with UI and mobility limitations. Unlike current PFMT, an innovative multimodal strengthening and aerobic conditioning rehabilitation program combined with PFMT will focus on overall physical function using a patient-centered individual approach, evaluate and treat both UI and mobility limitations. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from PFMT. We anticipate that this approach will enhance the benefits of PFMT because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women with UI. Thus, not only it will improve UI symptoms, but also decrease mobility limitations.

Objective evaluation of mobility and MRI muscle fat infiltration and atrophy in older women with UI will give us better understanding in pathophysiology of UI and mobility limitations in older women. Muscle fat infiltration and atrophy assessment of the pelvic floor and gluteal muscles in older women is novel and may represent a biomarker which serves as a predictor of treatment success in the evaluation and management of UI and mobility in older women.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle and Functional Assessment in Leakage Study
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Multi-modal rehabilitation program
12 weeks of various exercises
Other: Multi-modal rehabilitation program
Patients will receive 12 weeks of exercises.

Active Comparator: Pelvic Floor Physical therapy
12 weeks of standard pelvic floor physical therapy
Other: Pelvic Floor Physical therapy
Pelvic Floor Physical therapy

Primary Outcome Measures :
  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 Outcome Measures :
  1. muscle strength [ Time Frame: 12 weeks ]
    functional assessment

  2. muscle quality [ Time Frame: 12 weeks ]
    MRI evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Women ≥ 70 years older
  2. Symptomatic UI
  3. Symptoms ≥ 3 months
  4. Episodes of UI on 3-day bladder diary
  5. Stress, urgency, and mixed UI
  6. Self-reported functional or mobility limitations

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03166150

Contact: Sabina Salimova, M.D. (443)255-5305

Sponsors and Collaborators
Baltimore VA Medical Center
Principal Investigator: Tatiana Sanses, M.D. University of Maryland

Responsible Party: Tatiana Sanses, MD, FACOG, Assistant Professor, Baltimore VA Medical Center Identifier: NCT03166150     History of Changes
Other Study ID Numbers: HP-00066737
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tatiana Sanses, Baltimore VA Medical Center:
Urinary Incontinence, pelvic floor muscle training

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders