Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT01465594
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2011-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2011-11-02', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superiority of suprapubic catheter after EERPE', 'timeFrame': '2nd postoperative day', 'description': 'Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort'}], 'secondaryOutcomes': [{'measure': 'Comparison of QoL in both arms measured by visual analogue (pain) scale', 'timeFrame': '1st and 3rd until 5th postoperative day', 'description': 'Comparison of QoL in both arms measured by visual analogue (pain) scale, EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Measurement'], 'conditions': ['Pain', 'Catheter Complications']}, 'descriptionModule': {'briefSummary': 'The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.', 'detailedDescription': 'Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adenocarcinoma of the prostate,\n* Subjects treated by conventional or robotic assisted laparoscopic prostatectomy\n* Be willing/able to adhere to follow up visits\n\nExclusion Criteria:\n\n* Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer\n* Contraindications for anticholinergic drugs\n* Waist measurement \\> 100 cm\n* No written informed consent\n* Age \\< 18 years\n* Subjects with known narrow-angle glaucoma'}, 'identificationModule': {'nctId': 'NCT01465594', 'briefTitle': 'Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'catheterstudy001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transurethral catheter after EERPE/ RALP', 'description': 'Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics', 'interventionNames': ['Procedure: transurethral catheter after EERPE/ RALP', 'Procedure: suprapubic catheter after EERPE /RALP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'suprapubic catheter after EERPE /RALP', 'description': 'Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics', 'interventionNames': ['Procedure: transurethral catheter after EERPE/ RALP', 'Procedure: suprapubic catheter after EERPE /RALP']}], 'interventions': [{'name': 'transurethral catheter after EERPE/ RALP', 'type': 'PROCEDURE', 'description': 'transurethral catheter after EERPE/ RALP', 'armGroupLabels': ['suprapubic catheter after EERPE /RALP', 'transurethral catheter after EERPE/ RALP']}, {'name': 'suprapubic catheter after EERPE /RALP', 'type': 'PROCEDURE', 'description': 'suprapubic catheter after EERPE /RALP', 'armGroupLabels': ['suprapubic catheter after EERPE /RALP', 'transurethral catheter after EERPE/ RALP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University Hospital, Urological department', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Christian Arsov, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heinrich Heine Universität'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}