Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-24 @ 4:05 AM
Study NCT ID:
NCT02759705
Status:
WITHDRAWN
Last Update Posted:
2019-03-13
First Post:
2016-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D001746', 'term': 'Bladder Exstrophy'}, {'id': 'D004842', 'term': 'Epispadias'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'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': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014522', 'term': 'Urethral Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'no staff available to do the research', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'paternity rate', 'timeFrame': 'Baseline (at first consultation)', 'description': 'paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses'}, {'measure': 'Sperm quality', 'timeFrame': 'up to 2 months', 'description': 'concentration of mobile live sperm in semen analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fertility', 'sexuality', 'male', 'exstrophy-epispadias complex', 'bladder exstrophy', 'epispadias'], 'conditions': ['Fertility']}, 'descriptionModule': {'briefSummary': 'This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male patients born with classic bladder exstrophy or epipadias', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients followed the Hospices Civils de Lyon\n* Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology\n* Aged over 18 years\n* Born with classic bladder exstrophy or epispadias.\n\nExclusion Criteria:\n\n* Refusal of participation\n* Refusal to sign consent\n* minor Patients or protected major, under guardianship\n* Patients unable to understand the course of the study\n* cloacal exstrophy'}, 'identificationModule': {'nctId': 'NCT02759705', 'acronym': 'FIVES', 'briefTitle': 'Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?', 'orgStudyIdInfo': {'id': '69HCL16_0044'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Etienne TERRIER, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}