Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT01763957
Status:
WITHDRAWN
Last Update Posted:
2013-10-11
First Post:
2012-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D009948', 'term': 'Orgasm'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-10', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the quantity of urinary leakage, measured by the one hour pad test', 'timeFrame': '1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention', 'description': 'To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI'}], 'secondaryOutcomes': [{'measure': 'change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID', 'timeFrame': '1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention'}, {'measure': 'improvement of sexual function', 'timeFrame': '1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention', 'description': 'To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI'}, {'measure': 'improvement of quality of life', 'timeFrame': '1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention', 'description': 'To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence', 'Sexual Satisfaction', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women after menopause (12 months with no period)\n* aged 40 or more\n* have a positive pad test leakage of 1-50 grams\n* no systemic or local hormonal therapy\n* literate in Hebrew and/or English\n\nExclusion Criteria:\n\n* women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)\n* pelvic surgery within the last 6 months\n* post hysterectomy or oophorectomy genital prolapse grade 3 or higher'}, 'identificationModule': {'nctId': 'NCT01763957', 'briefTitle': 'Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Paula/PFMT-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic Floor Muscle Training (PFMT)', 'interventionNames': ['Behavioral: Pelvic Floor Muscle Training (PFMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paula Method', 'interventionNames': ['Behavioral: Paula Method']}], 'interventions': [{'name': 'Paula Method', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Paula Method']}, {'name': 'Pelvic Floor Muscle Training (PFMT)', 'type': 'BEHAVIORAL', '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 .', 'armGroupLabels': ['Pelvic Floor Muscle Training (PFMT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Drorith Hochner-Celnikier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}