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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118557
Other study ID # 17-001061
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2017
Est. completion date December 11, 2017

Study information

Verified date March 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 11, 2017
Est. primary completion date December 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
Pilates pelvic floor strengthening
Pilates pelvic floor strengthening.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline, 12 weeks
Secondary 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. Baseline, 12 weeks
Secondary 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). Baseline, 12 weeks
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