Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

Not Applicable

Withdrawn

• Conditions: Sexual Satisfaction; Quality of Life; Stress Urinary Incontinence
• Interventions: Behavioral: Pelvic Floor Muscle Training (PFMT); Behavioral: Paula Method

• Registration Number: NCT01763957
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Start: 2013-03
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11
• Primary Completion: 2015-03
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Muscle Training (PFMT)	Pelvic Floor Muscle Training (PFMT)	-
Paula Method	Paula Method	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel