Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

March 21, 2019 updated by: Deborah Rhodes, Mayo Clinic

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.

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilates pelvic floor strengthening exercise
Other: Pilates pelvic floor strengthening
Pilates pelvic floor strengthening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks
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).
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Deborah J Rhodes, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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