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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01763957
First received: December 17, 2012
Last updated: October 10, 2013
Last verified: December 2012
  Purpose

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 Intervention
Stress Urinary Incontinence
Sexual Satisfaction
Quality of Life
Behavioral: Paula Method
Behavioral: Pelvic Floor Muscle Training (PFMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • change in the quantity of urinary leakage, measured by the one hour pad test [ Time Frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention ] [ Designated as safety issue: No ]
  • improvement of sexual function [ Time Frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI

  • improvement of quality of life [ Time Frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention ] [ Designated as safety issue: No ]
    To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI


Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763957

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner-Celnikier, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01763957     History of Changes
Other Study ID Numbers: Paula/PFMT-HMO-CTIL
Study First Received: December 17, 2012
Last Updated: October 10, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014