Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT01737918
Status:
UNKNOWN
Last Update Posted:
2015-04-07
First Post:
2012-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cure of incontinence', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'improvement of urge symptoms', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['urge urinary incontinence, cesa, vasa, TOT, solifenacin'], 'conditions': ['Surgical Treatment of Urge Incontinence']}, 'descriptionModule': {'briefSummary': 'Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.', 'detailedDescription': 'It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prior vasa or cesa operation as part of the URGE I study\n* stress urinary incontinence\n* mixed urinary incontinence\n\nExclusion Criteria:\n\n* previous urogynecological surgery\n* avulsion of cesa or vasa tape\n* pregnancy\n* neurologic/psychological reasons for incontinence\n* body weight \\>100kg\n* syndrome of dry overactive bladder'}, 'identificationModule': {'nctId': 'NCT01737918', 'acronym': 'URGE-II', 'briefTitle': 'Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum der Universität Köln'}, 'officialTitle': 'Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence', 'orgStudyIdInfo': {'id': 'URGE-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trans obturatorial tape (TOT)', 'description': 'placement of a sub-urethral tape', 'interventionNames': ['Procedure: TOT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'solifenacin', 'description': '10 mg per day', 'interventionNames': ['Drug: solifenacin']}], 'interventions': [{'name': 'TOT', 'type': 'PROCEDURE', 'otherNames': ['trans obturatorial tape'], 'armGroupLabels': ['trans obturatorial tape (TOT)']}, {'name': 'solifenacin', 'type': 'DRUG', 'otherNames': ['VESICUR 10mg per day'], 'armGroupLabels': ['solifenacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfram H Jager, PhD', 'role': 'CONTACT', 'email': 'wolfram.jaeger@uk-koeln.de', 'phone': '0049221478', 'phoneExt': '4900'}], 'facility': 'Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50931', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfram H Jager, PhD', 'role': 'CONTACT', 'email': 'wolfram.jaeger@uk-koeln.de', 'phone': '0049221478', 'phoneExt': '4900'}, {'name': 'Peter Mallmann, PhD', 'role': 'CONTACT', 'email': 'peter.mallmann@uk-koeln.de', 'phone': '0049221478', 'phoneExt': '4940'}, {'name': 'Wolfram H Jager, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Wolfram H Jager, PhD', 'role': 'CONTACT', 'email': 'wolfram.jaeger@uk-koeln.de', 'phone': '0049221478', 'phoneExt': '4900'}, {'name': 'Peter Mallmann, PhD', 'role': 'CONTACT', 'email': 'peter.mallmann@uk-koeln.de', 'phone': '0049221478', 'phoneExt': '4940'}], 'overallOfficials': [{'name': 'Wolfram H Jager, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Supervisor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum der Universität Köln', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Dr. Wolfram Jäger', 'investigatorAffiliation': 'Klinikum der Universität Köln'}}}}