Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118557
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic

Brief Summary:
Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Other: Pilates pelvic floor strengthening Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: HLP-16-003H: Does a Twice Weekly, 12-week Pilates Pelvic Floor Strengthening Program Improve Short- and Long-term Measures of Stress Urinary Incontinence Symptoms in Women Ages 45-70 Years of Age.
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilates pelvic floor strengthening exercise Other: Pilates pelvic floor strengthening
Pilates pelvic floor strengthening.




Primary Outcome Measures :
  1. Change in score on International Consultation on Incontinence (ICIQ-UI Short Form) [ Time Frame: Baseline, 12 weeks ]
    The ICIQ-UI Short Form consists of 3 questions. The ICIQ score is a sum of the responses to the 3 questions with a total possible range of 0 (none) to 21 (all the time/a great deal).


Secondary Outcome Measures :
  1. Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire [ Time Frame: Baseline, 12 weeks ]
    The MESA Urinary Incontinence Questionnaire consists of 3 sections: General questions (unscored), Urge Incontinence (6 questions), and Stress Incontinence (9 questions). The scored questions can range from 0 (never) to 3 (often). The score for the Urge Incontinence is the sum of the responses/18, and the score for the Stress Incontinence section is the sum of the responses/27.

  2. Change in score on Linear Analogue Self Assessment (LASA) [ Time Frame: Baseline, 12 weeks ]
    The LASA questionnaire consists of 6 questions, each ranging from 0 (as bad as it can be) to 10 (as good as it can be). Therefore, the total possible scores would range from 0 (as bad as it can be) to 60 (as good as it can be).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 45-70 years of age.
  2. Able to provide informed consent.
  3. Able to lower and rise from the floor safely and independently.
  4. Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6.
  5. Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12.
  6. Score of 6+ on ICIQ-UI Short Form.

Exclusion Criteria:

  1. Pregnancy
  2. Unable to speak and comprehend English
  3. Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.

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 ClinicalTrials.gov identifier (NCT number): NCT03118557


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Deborah J Rhodes Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Deborah Rhodes, MD, Associate Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03118557    
Other Study ID Numbers: 17-001061
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Rhodes, Mayo Clinic:
pelvic floor
strengthening
Stress
urinary
incontinence
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders