Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 7:38 PM
Study NCT ID:
NCT05689866
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bladder-sphincter Symptoms in Functional Neurological Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of at least one bladder-sphincter disorder', 'timeFrame': 'inclusion', 'description': 'This primary endpoint will be measured by the score of the questionnairies which will define the presence of a vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5)'}], 'secondaryOutcomes': [{'measure': 'evaluate the nature of bladder and bowel disorders in patients with NFT', 'timeFrame': 'inclusion', 'description': 'the score of the different questionnairies vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5) that will define the presence of a bladder symptoms'}, {'measure': 'Assess the persistence of bladder and sphincter complaints in patients with NFTs', 'timeFrame': '24months', 'description': 'the score of the questionnairies vesicosphincter disorder (USP), anorectal disorder (Kess and Wexner) or sexual genital disorder (FSFI/IIEF5) that will define the presence of a bladder symptoms'}, {'measure': 'Evaluate whether patients with significant vesico-sphincter complaints differ from patients without complaints, including demographic, traumatic, and NFT semiology.', 'timeFrame': '24months', 'description': 'comparison of the characteristics of patients on the vesico-sphincter level'}, {'measure': 'To assess whether the clinical and paraclinical patterns of bladder and sphincter disorders differ according to the type of NFT.', 'timeFrame': '24months', 'description': 'Analysis of urodynamic assessment data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Bladder Sphincter Disorder']}, 'descriptionModule': {'briefSummary': 'A significant proportion of patients with functional neurological disorders (FND) report urinary, anorectal or genitosexual disorders. However, until now, no study has focused on bladder-sphincter disorders in patients with FND. The symptoms of this pathology are, therefore, not precisely characterized.\n\nThus, the objective of this research is to specify if urinary, anorectal or sexual disorders can be observed in patients suffering from functional neurological disorders and to better describe them in order to propose better therapeutic options.', 'detailedDescription': 'In this clinical study the investigators want to prospectively include all patients presenting to a neurology consultation or day hospital for management of a motor or sensory FND.The patients will first be evaluated for their sphincter functions by self questionnaires. For those where a vesico-sphincter complaint is demonstrated, a neuro-urological consultation will be proposed. A follow-up will then be done, if necessary, in neurology and neuro-urology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to a neurology consultation or day hospital for management of a functional motor or sensory disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years of age\n* Diagnosis of Functional Neurological Disorders according to DSM 5 criteria\n* No neurological comorbidity that could account for the sphincter disorders\n* Normal cerebral and spinal cord magnetic resonance imaging.\n* Patient affiliated to a French social security system\n* Patient informed and not objecting to participate in the study\n\nNon inclusion Criteria :\n\n* Presence of neurological comorbidity that can account for sphincter disorders (e.g. multiple sclerosis, chronic neuropathy, etc.)\n* Pregnancy in progress\n* Candidate for surgery or locoregional treatment\n* Patient subject to legal protection measures.\n* Patient under state medical assistance'}, 'identificationModule': {'nctId': 'NCT05689866', 'acronym': 'URO-TNF', 'briefTitle': 'Study of Bladder-sphincter Symptoms in Functional Neurological Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Bladder-sphincter Symptoms in Functional Neurological Disorders', 'orgStudyIdInfo': {'id': 'APHP221001'}}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hospital Avicenne-Neurology', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'centralContacts': [{'name': 'Béatrice GARCIN, Dr', 'role': 'CONTACT', 'email': 'beatrice.garcin@aphp.fr', 'phone': '01 48 95 54 01'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}