Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

Study Overview
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Brief Summary
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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?

Official Title
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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.

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Other: Pilates pelvic floor strengthening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates pelvic floor strengthening exercise<br> | Other: Pilates pelvic floor strengthening<br>* Pilates pelvic floor strengthening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor, strengthening, Stress, urinary, incontinence