Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-21 @ 9:10 PM
Study NCT ID:
NCT02381912
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D006417', 'term': 'Hematuria'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sexual function', 'timeFrame': '4 months', 'description': 'Change in sexual function measured by the "EORTC QLQ-BLS24 sexual functioning questions"'}], 'secondaryOutcomes': [{'measure': 'Change in erectile function', 'timeFrame': '4 months', 'description': 'Change in erectile function measured by the Erection Hardness Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Bladder Neoplasms', 'Sexual Dysfunction, Physiological', 'Sexual Dysfunctions, Psychological', 'Erectile Dysfunction', 'Hematuria']}, 'referencesModule': {'references': [{'pmid': '25356311', 'type': 'BACKGROUND', 'citation': 'Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med. 2014 Aug;2(3):141-51. doi: 10.1002/sm2.24.'}, {'pmid': '19154473', 'type': 'BACKGROUND', 'citation': 'van der Aa MN, Bekker MD, van der Kwast TH, Essink-Bot ML, Steyerberg EW, Zwarthoff EC, Sen FE, Elzevier HW. Sexual function of patients under surveillance for bladder cancer. BJU Int. 2009 Jul;104(1):35-40. doi: 10.1111/j.1464-410X.2008.08333.x. Epub 2009 Jan 14.'}, {'pmid': '22461137', 'type': 'BACKGROUND', 'citation': 'Goossens-Laan CA, Kil PJ, Ruud Bosch JL, De Vries J. Pre-diagnosis quality of life (QoL) in patients with hematuria: comparison of bladder cancer with other causes. Qual Life Res. 2013 Mar;22(2):309-15. doi: 10.1007/s11136-012-0163-1. Epub 2012 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate sexual function in patients suspected of non muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual function is underdiagnosed in patients with non-muscle invasive bladder cancer and that active examination and treatment may worsen the sexual function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary hematuria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary hematuria, both gross and microscopic\n* Men and women older or equal to 40 years of age\n* Signed informed consent statement\n\nExclusion Criteria:\n\n* Men and women younger than 40 years of age\n* Patients with recurrent hematuria and known causative disease\n* Already known urogenital cancer\n* Previous massive pelvic surgery or pelvic radiotherapy\n* TUR-P within the last 2 months\n* Participants diagnosed with tumors originating from the ureters, renal pelvis and kidney, and bladder tumors at T stage more than or equal to T1b.'}, 'identificationModule': {'nctId': 'NCT02381912', 'briefTitle': 'Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'SSBC-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hematuria - NMIBC', 'description': 'Primary hematuria due to NMIBC.', 'interventionNames': ['Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire']}, {'label': 'Hematuria - other cause', 'description': 'Other non-malignant cause of hematuria.', 'interventionNames': ['Other: EORTC QLQ-C30 and EORTC BLS-24 questionnaire']}], 'interventions': [{'name': 'EORTC QLQ-C30 and EORTC BLS-24 questionnaire', 'type': 'OTHER', 'description': 'Questionnaires answered at baseline and 4 months follow up.', 'armGroupLabels': ['Hematuria - NMIBC', 'Hematuria - other cause']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Peter B Østergren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital, Department of Urology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Peter Busch Østergren', 'investigatorAffiliation': 'Herlev Hospital'}}}}