Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT01445834
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2011-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2011-09-30', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients reported outcome regarding their urinary incontinence', 'timeFrame': '2003-2009 (up to 6 years)'}], 'secondaryOutcomes': [{'measure': 'Physiotherapists reported outcome after finishing the pelvic floor muscle training', 'timeFrame': '2003-2008 (up to 5 years)'}, {'measure': 'need of incontinence surgery after conservative treatment in the follow up of at least 2 years', 'timeFrame': 'follow up of at least 2 years after physiotherapy that was performed between 2003-2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['outcome of pelvic floor muscle physiotherapy', 'female', 'stress urinary incontinence', 'urgency urinary incontinence', 'mixed urinary incontinence'], 'conditions': ['Stress Urinary Incontinence', 'Urge Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement.\n\nComparison of two age groups, controlled for BMI, parity and previous incontinence operations.', 'detailedDescription': 'Pelvic floor muscle exercise is an established conservative treatment for female urinary incontinence. Up to now, the investigators don\'t know whether treatment outcome in elderly women is as good as in younger premenopausal women. The International Incontinence Society states 2009: "There is no good evidence to date to suggest that "healthy" older women with urinary incontinence do not benefit from pelvic floor muscle training as much as younger women".\n\nIn this retrospective study the investigators analyze patient charts from 2003-2008 regarding subjective patients and physiotherapists reported outcome after physiotherapy as well as for objective parameters like the need of an incontinence surgery in the follow-up of at least 2 years.\n\nEligibility criteria are age younger than 50 years (premenopausal) and age older than 65 years and a urodynamically proven urinary incontinence. As incontinence forms the investigators include in this study the following three form: stress urinary incontinence, mixed urinary incontinence and urgency urinary incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women from a tertiary referral center with urodynamically proven incontinence willig to perform physiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premenopausal women (\\<50 years) with urodynamically proven urinary incontinence\n* postmenopausal women (\\>65 years) with urodynamically proven urinary incontinence\n* 9 sessions of pelvic floor muscle exercise in a professional kinesiological setting inbetween 2003-2008\n* follow up regarding need of incontinence operation up to June 2011\n\nExclusion Criteria:\n\n* women aged 50-65 years with urodynamically proven urinary incontinence\n* stool incontinence'}, 'identificationModule': {'nctId': 'NCT01445834', 'briefTitle': 'Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Retrospective Study About the Age-stratified Outcome of Pelvic Floor Muscle Exercise for Stress (SUI), Mixed (MUI) and Urgency Urinary Incontinence (UUI) 2003-2008', 'orgStudyIdInfo': {'id': 'KEK-ZH2011/0299/0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Incontinent women'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Cornelia Betschart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Urogynecology, MD', 'investigatorFullName': 'Cornelia Betschart', 'investigatorAffiliation': 'University of Zurich'}}}}