Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence
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.
1 other identifier
interventional
27
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2017
CompletedMarch 25, 2019
March 1, 2019
8 months
April 13, 2017
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in score on Medical, Epidemiological, Social Aging (MESA) Urinary Incontinence Questionnaire
Baseline, 12 weeks
Change in score on Linear Analogue Self Assessment (LASA)
Baseline, 12 weeks
Study Arms (1)
Pilates pelvic floor strengthening exercise
EXPERIMENTALInterventions
Pilates pelvic floor strengthening.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy
- Unable to speak and comprehend English
- Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah J Rhodes
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Associate Professor of Medicine, College of Medicine
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
April 19, 2017
Primary Completion
December 11, 2017
Study Completion
December 11, 2017
Last Updated
March 25, 2019
Record last verified: 2019-03