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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Withdrawn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
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
December 17, 2012
Last Updated
October 10, 2013
Sponsor
Hadassah Medical Organization
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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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