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Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilates pelvic floor strengthening
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress Urinary Incontinence focused on measuring pelvic floor, strengthening, Stress, urinary, incontinence

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilates pelvic floor strengthening exercise

Arm Description

Outcomes

Primary Outcome Measures

Change in score on International Consultation on Incontinence (ICIQ-UI Short Form)
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

Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire
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.
Change in score on Linear Analogue Self Assessment (LASA)
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).

Full Information

First Posted
April 13, 2017
Last Updated
March 21, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03118557
Brief Title
Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
pelvic floor, strengthening, Stress, urinary, incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates pelvic floor strengthening exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pilates pelvic floor strengthening
Intervention Description
Pilates pelvic floor strengthening.
Primary Outcome Measure Information:
Title
Change in score on International Consultation on Incontinence (ICIQ-UI Short Form)
Description
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).
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in score on Linear Analogue Self Assessment (LASA)
Description
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).
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 45-70 years of age. Able to provide informed consent. Able to lower and rise from the floor safely and independently. Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6. Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12. Score of 6+ on ICIQ-UI Short Form. Exclusion Criteria: Pregnancy Unable to speak and comprehend English Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J Rhodes
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

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