Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT01971294
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2013-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract Symptoms in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'ACTUAL', 'count': 334}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence/incidence of urinary symptoms in scleroderma', 'timeFrame': 'Inclusion and every year for 2 years'}], 'secondaryOutcomes': [{'measure': 'Short Form 36 Health Survey (SF-36)', 'timeFrame': 'At inclusion and after 2 years', 'description': 'Quality of life (lower, better)'}, {'measure': 'Mortality', 'timeFrame': 'During two years'}, {'measure': 'Urinary tract infection', 'timeFrame': 'During two years'}, {'measure': 'Incontinence Quality of Life (IQol)', 'timeFrame': 'At inclusion and after 2 years', 'description': 'Quality of life (0-100; higher, better), specific for urinary incontinence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary symptoms', 'Systemic sclerosis', 'Severity index', 'Urinary tract infection', 'mortality', 'Quality of life'], 'conditions': ['Urinary Symptoms', 'Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '29073343', 'type': 'DERIVED', 'citation': 'John G, Avouac J, Piantoni S, Polito P, Fredi M, Cozzi F, Airo P, Truchetet ME, Franceschini F, Allanore Y, Chizzolini C. Prevalence and Disease-Specific Risk Factors for Lower Urinary Tract Symptoms in Systemic Sclerosis: An International Multicenter Study. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1218-1227. doi: 10.1002/acr.23454. Epub 2018 Jun 19.'}, {'pmid': '28977630', 'type': 'DERIVED', 'citation': 'John G, Allanore Y, Polito P, Piantoni S, Fredi M, Avouac J, Franceschini F, Truchetet ME, Cozzi F, Airo P, Chizzolini C. The limited cutaneous form of systemic sclerosis is associated with urinary incontinence: an international multicentre study. Rheumatology (Oxford). 2017 Nov 1;56(11):1874-1883. doi: 10.1093/rheumatology/kex230.'}]}, 'descriptionModule': {'briefSummary': 'Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown.\n\nUrinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death.\n\nThus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death.\n\nThis study will also give basement to build an interventional study directed toward LUTS treatment in this population.\n\nIn this prospective cohort we would like to:\n\n* Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis.\n* Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis.\n* Evaluate the impact of LUTS symptoms on Quality of life.\n* Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population.\n* Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Systemic sclerosis suffering patients in Brescia (I), Geneva (CH), Padova (I) and Paris (F)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).\n\nExclusion Criteria:\n\nThose unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients'}, 'identificationModule': {'nctId': 'NCT01971294', 'briefTitle': 'Lower Urinary Tract Symptoms in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study', 'orgStudyIdInfo': {'id': 'CER 12-291'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systemic sclerosis', 'description': 'Adult suffering from systemic sclerosis included in the EUSTAR network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '25124', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '35121', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Universtiy Hospital, Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Carlo Chizzolini, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Geneva'}, {'name': 'Yannick Allanor, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Département de médecine interne, Hôpital Cochin, Paris'}, {'name': 'Franco Cozzi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, Azienda Ospedaliera di Padova, Padova (I)'}, {'name': 'Paolo Airo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)'}, {'name': 'Franco Franceschini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia (I)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Paris', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}, {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gregor John', 'investigatorFullName': 'Gregor John', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}