Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-29 @ 11:07 PM
Study NCT ID:
NCT04964895
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Quality of Patients After Bladder Cancer Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy', 'timeFrame': 'T0 : before surgery', 'description': 'EORTC SHQ C22 score before surgery'}, {'measure': 'Evaluation of the decrease in the quality of sexual life of patients who had a cystectomy', 'timeFrame': 'T1 : 8 months after surgery', 'description': 'EORTC SHQ C22 score 8 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the decrease in the quality of life of patients who had a cystectomy', 'timeFrame': 'T0 : before surgery', 'description': 'QLQ-C30 score before surgery'}, {'measure': 'Evaluation of the decrease in the quality of life of patients who had a cystectomy', 'timeFrame': 'T1 : 8 months after surgery', 'description': 'QLQ-C30 score 8 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder cancer', 'cystectomy', 'sex life', 'sex quality'], 'conditions': ['Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant chemotherapy followed by radical cystectomy associated with reconstruction of the urinary tract. The short-term effects on well-being and quality of life are well known. The long-term effects are, on the other hand, poorly understood, particularly sexual function. This study aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This will be done via various questionnaires given before and after surgery.', 'detailedDescription': 'The study is a prospective observational cohort study of the quality of sexual life in patients with cystectomy for bladder cancer. Data is collected via Qlq-C30, EORTC-Shq22, MSHQ if male, Female Sexual Function Index (FSFI) questionnaires that the patients complete by themselves. They are given before surgery and then 8 months after surgery.\n\nThe study consists of the compilation of relevant clinical data and questionnaire results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient who underwent cystectomy for bladder cancer during the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient who had a cystectomy for bladder cancer\n* Affiliated with a social security scheme\n\nExclusion Criteria:\n\n* No Cystectomy\n* Cystectomy for neurological etiology\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04964895', 'acronym': 'QSCO', 'briefTitle': 'Sexual Quality of Patients After Bladder Cancer Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Sexual Quality of Patients After Bladder Cancer Cystectomy : A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RC31/21/0113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with cystectomy', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Patients will fill in multiple questionnaires for this study :\n\nEORTC quality of life questionnaire (QLQ) QLQ-C30, EORTC Shq22, Male Sexual Health Questionnaire (MSHQ) only for Men, FSFI (only for women)', 'armGroupLabels': ['patients with cystectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Eric Huyghe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}