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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Stress Urinary Incontinence; Sexual Satisfaction
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training (PFMT); Behavioral: Paula Method

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
improvement of quality of life	To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 11, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: Paula/PFMT-HMO-CTIL