Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT05844059
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract Symptoms After Intravesical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-04-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2023-04-22', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of instillation therapy on quality of life', 'timeFrame': 'During the study period approximately 12 months', 'description': 'Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol'}, {'measure': 'Effect of instillation therapy on sexuality', 'timeFrame': 'During the study period approximately 12 months', 'description': 'Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women)'}, {'measure': 'Effect of instillation therapy on lower urinary tract symptoms', 'timeFrame': 'During the study period approximately 12 months', 'description': 'Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women)'}], 'secondaryOutcomes': [{'measure': 'Complications during instillation therapy', 'timeFrame': 'During the study period approximately 12 months', 'description': 'The frequency of all complications will be measured and will be subsequently classified based on the Clavien-Dindo classification'}, {'measure': 'Discontinuation rate of instillation therapy', 'timeFrame': 'During the study period approximately 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy Effect', 'Chemotherapeutic Toxicity', 'Lower Urinary Tract Symptoms', 'Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with urinary bladder carcinoma requiring instillation therapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urinary bladder carcinoma requiring instillation therapy\n* Complete resection of the tumor\n* No intravesical chemotherapy in the last 3 months\n\nExclusion Criteria:\n\n* Patients who are unable to complete the questionnaires\n* Patients who are not willing to participate\n* Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)'}, 'identificationModule': {'nctId': 'NCT05844059', 'acronym': 'LUTSI', 'briefTitle': 'Lower Urinary Tract Symptoms After Intravesical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder', 'orgStudyIdInfo': {'id': '23-0226'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing instillation therapy with BCG', 'description': 'All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer', 'interventionNames': ['Other: Validated questionnaires']}, {'label': 'Patients undergoing instillation therapy with Mitomycin C', 'description': 'All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer', 'interventionNames': ['Other: Validated questionnaires']}], 'interventions': [{'name': 'Validated questionnaires', 'type': 'OTHER', 'description': 'BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS', 'armGroupLabels': ['Patients undergoing instillation therapy with BCG', 'Patients undergoing instillation therapy with Mitomycin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nikolaos Pyrgidis', 'role': 'CONTACT', 'email': 'nikolaos.pyrgidis@med.uni-muenchen.de', 'phone': '004989440073531'}], 'facility': 'Nikolaos Pyrgidis', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Nikolaos Pyrgidis, Urologist', 'role': 'CONTACT', 'email': 'nikolaos.pyrgidis@med.uni-muenchen.de', 'phone': '004989440073531'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Benedikt Ebner', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}