Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
Study Details
Study Description
Brief Summary
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pelvic Floor Muscle Training (PFMT)
|
Behavioral: Pelvic Floor Muscle Training (PFMT)
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list .
|
| Active Comparator: Paula Method
|
Behavioral: Paula Method
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list.
|
Outcome Measures
Primary Outcome Measures
- change in the quantity of urinary leakage, measured by the one hour pad test [1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention]
To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI
Secondary Outcome Measures
- change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID [1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention]
- improvement of sexual function [1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention]
To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI
- improvement of quality of life [1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention]
To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI
Eligibility Criteria
Criteria
Inclusion Criteria:
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women after menopause (12 months with no period)
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aged 40 or more
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have a positive pad test leakage of 1-50 grams
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no systemic or local hormonal therapy
-
literate in Hebrew and/or English
Exclusion Criteria:
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women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
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pelvic surgery within the last 6 months
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post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hadassah Medical Organization | Jerusalem | Israel |
Sponsors and Collaborators
- Hadassah Medical Organization
Investigators
- Principal Investigator: Drorith Hochner-Celnikier, MD, Hadassah Medical Organization
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Paula/PFMT-HMO-CTIL