Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
Primary Purpose
Stress Urinary Incontinence, Sexual Satisfaction, Quality of Life
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Paula Method
Pelvic Floor Muscle Training (PFMT)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- women after menopause (12 months with no period)
- aged 40 or more
- have a positive pad test leakage of 1-50 grams
- no systemic or local hormonal therapy
- literate in Hebrew and/or English
Exclusion Criteria:
- women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
- pelvic surgery within the last 6 months
- post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pelvic Floor Muscle Training (PFMT)
Paula Method
Arm Description
Outcomes
Primary Outcome Measures
change in the quantity of urinary leakage, measured by the one hour pad test
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
improvement of sexual function
To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI
improvement of quality of life
To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI
Full Information
NCT ID
NCT01763957
First Posted
December 17, 2012
Last Updated
October 10, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01763957
Brief Title
Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
Official Title
The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Sexual Satisfaction, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic Floor Muscle Training (PFMT)
Arm Type
Active Comparator
Arm Title
Paula Method
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Paula Method
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Muscle Training (PFMT)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
change in the quantity of urinary leakage, measured by the one hour pad test
Description
To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI
Time Frame
1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Secondary Outcome Measure Information:
Title
change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID
Time Frame
1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Title
improvement of sexual function
Description
To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI
Time Frame
1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Title
improvement of quality of life
Description
To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI
Time Frame
1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women after menopause (12 months with no period)
aged 40 or more
have a positive pad test leakage of 1-50 grams
no systemic or local hormonal therapy
literate in Hebrew and/or English
Exclusion Criteria:
women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
pelvic surgery within the last 6 months
post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drorith Hochner-Celnikier, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
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