Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-08 @ 4:12 AM
Study NCT ID:
NCT03189056
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2017-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003404', 'term': 'Creatinine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic patients', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'ICIQ SF\\>0 IPSS\\>7 or past acute urinary retention IIEF5\\<11'}], 'secondaryOutcomes': [{'measure': 'Megabladder', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'Bladder capacity \\>600cc and \\<4 daily micturition'}, {'measure': 'Mega ureter', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'Ultrasonographic dilatation of renal pelvis\\>20mm or of ureter \\>7mm'}, {'measure': 'Hyperactive bladder', 'timeFrame': 'micturition calendar over 2 days (transversal study, the participant will not be followed)', 'description': '\\>8 daily micturition + urgency on dairy subsection detrusor hyperactivity on cystomanometry'}, {'measure': 'Detrusor underactivity', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'Qmax\\<15 mL/s and post void residual\\>150cc per-micturition pressure \\<40 cm H2O'}, {'measure': 'Renal insufficiency', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'CDK EPI\\<60 mL/mn'}, {'measure': 'Urinary recurrent infections', 'timeFrame': 'reported infections duing the last 5 years (transversal study, the participant will not be followed)', 'description': 'past history \\> 3 pyélonephritis or \\>5 cystitis/year in the past 5 years, if associated with dilatated ureter/renal pelvis or significant post void residual'}, {'measure': 'Urinary sphincter insufficiency', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'P max\\<30 cm H20 and stress urinary incontinence'}, {'measure': 'Erectile dysfunction in males', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'IIEF5 \\<16'}, {'measure': 'Hypofertility', 'timeFrame': 'at consultation : 1 day (transversal study, the participant will not be followed)', 'description': 'oral assess by difficulty to obtain pregnancy \\>1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic Chagas disease', 'bladder', 'lower urinary tract', 'urodynamic'], 'conditions': ["Chagas' Disease (Chronic) With Other Organ Involvement"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/B978-0-12-385863-4.00009-5', 'label': 'Jelicks, Linda A., et Herbert B. Tanowitz. " Advances in Imaging of Animal Models of Chagas Disease ". Advances in Parasitology 75 (2011): 193-208. doi:10.1016/B978-0-12-385863-4.00009-5.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701742/', 'label': 'Ny, Lars et al. " A Magnetic Resonance Imaging Study of Intestinal Dilation in Trypanosoma Cruzi-Infected Mice Deficient in Nitric Oxide Synthase ". The American Jour'}, {'url': 'http://dx.doi.org/10.1016/j.ijcard.2011.07.060', 'label': 'Ardito et al. " Chronic Renal Impairment in Patients with Chagas Cardiomyopathy with Chronic Systolic Heart Failure: Prevalence and Prognostic Significance ". Inte'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/14084752', 'label': 'Koeberle, F. " ENTEROMEGALY AND CARDIOMEGALY IN CHAGAS DISEASE ". Gut 4 (décembre 1963): 399-405.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/9030871', 'label': 'Mirkin et al. " Experimental Chagas\' Disease: Electrophysiology and Cell Composition of the Neuromyopathic Inflammatory Lesions in Mice Infected with a Myotropic and a Pantropic Strain of'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/12937767', 'label': 'Cabrine-Santos et al. " Genitourinary Changes in Hamsters Infected and Reinfected with Trypanosoma Cruzi ". Memórias Do Insti'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/10513065', 'label': 'Scremin, L. H., C. E. Corbett, M. D. Laurenti, E. V. Nunes, J. J. Gama-Rodrigues, et M. Okumura. " Megabladder in Experimental Chagas Disease: Pathological Features of the Bladder Wall ". Revista Do Hospital Das Clínicas 54, nᵒ 2 (avril 1999): 43-46.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/15745502', 'label': 'Suaid et al. " Modulation of Urethral Alpha-Sympathetic by Parasympathetic before and Following Bethanechol Chloride Injection ". International Braz J Urol: Official J'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/2851967', 'label': 'DeFaria, C. R., J. M. De Rezende, et A. Rassi. " \\[Peripheral denervation in the various clinical forms of Chagas\' disease\\] ". Arquivos De Neuro-Psiquiatria 46, nᵒ 3 (septembre 1988): 225-37.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/1590593', 'label': 'Carraro, A. A., R. A. Lopes, R. D. Ribeiro, et T. L. Lamano Carvalho. " The Male Reproductive Organs in the Chronic Phase of Experimental Chagas\' Disease ". Angewandte Parasitologie 33, nᵒ 1 (février 1992): 3-9.'}, {'url': 'http://www.scielo.br/scielo.php?script=sci_abstract&pid=S0102-86502001000500003&lng=en&nrm=iso&tlng=pt', 'label': 'Rocha, J. N., H. J. Suaid, A. C. P. Martins, A. J. Cologna, S. Tucci Jr., et M. A. Gonçalves. " URODYNAMIC ASSESSEMENT IN PATIENTS WITH CHAGAS DISEASE ". Acta Cirurgica Brasileira 16 (2001): 7-8. doi:10.1590/S0102-86502001000500003.'}]}, 'descriptionModule': {'briefSummary': "Chagas disease is one of the most neglected vector-borne infectious disease worldwide. The first decades following the discovery of the pathology drove an international research enthusiasm, mainly concentrated on understanding the typical cardiac and digestive forms. Recently, research have been focused on vector control, which has been a huge success, at the price of neglecting the patients who already presented fixed and severe organic lesions due the chronic phase of the illness.\n\nThis study focus on a rarely studied aspect of this pathology: the involvement of the lower urinary tract and it's symptomatology in adults suffering from Chagas chronic disease.\n\nVarious studies have assessed the involvement of the lower urinary tract in chronic Chagas disease, the vast majority of them being on the animal model or very ancient human studies mainly on cadaveric specimen, the first of them being the primary description of Koeberle in 1963.\n\nHuman symptomatology deriving from bladder, ureteral and urethral chronic chagasic lesions are yet widely unknown, and only a few Brazilian and Mexican studies have intended to describe the clinical and urodynamic presentation of these patients.\n\nThe aim of this study is to assess the prevalence of urinary disorders in chronic chagasic patients and to describe their symptoms, through a complete clinical, ultrasonographic and urodynamic description.", 'detailedDescription': "Epidemiologic observationnal transversal study\n\nCohort of patients between 18 and 50 years of age, presenting a chronic form of Chagas' disease (cardiopathy, mega-colon or mega-esofagus), and presenting non of the exclusion criteria.\n\nRecruitment via the existing patients list of positive Chagas serology of:\n\n* the SELADIS center (Instituto de Servicios de Laboratorio de Diagnostico e Investigacion en Salud UMSA -UNIVERSIDAD MAYOR DE SAN ANDRES-)\n* Private surrounding hospitals, Hospital de Clinicas and Centro de Seguro Social Universitario de La Paz (UMSA)\n* Laboratorio de Inmunodiagnostico Instituto Boliviano de Biologia de la Altura -IBBA-Dr Lourdes Echalar.\n\nInformed consent signed.\n\n1 to 3 consultations on a period of one to 2 weeks no follow-up (transversal study)\n\nInvasive descriptive explorations (blood sample and urodynamic study, imposing the assent of the Comité Nacional de Bioética).\n\nMain objective : Describe the prevalence of the lower urinary tract dysfunction in patients suffering from a chronic form of Chagas' disease. The main criteria evaluated is the sum of two symptom questionnaires IPSS and ICIQ (spanish official validated translation), focusing on urinary incontinence, voiding dysfunction and quality of life.\n\nSecondary objectives :\n\nAll the included patients will be proposed an initial consult :\n\n* Anonymization of all the observation/results\n* Past history (pathology, actual treatment,…), search of the exclusion criteria, Chagas' disease symptomatology and treatment, urological symptomatology.\n* Validated questionnaires to evaluate urological symptoms, urinary incontinence, voiding dysfunction or acute urinary dysfunction, bladder hyperactivity, sexuality and fertility.\n* Clinical examination\n* Micturition calendar /48hours.\n* Uroflowmetry, followed by ultrasonography for post-void residual and upper-urinary tract dilatation.\n* Blood sample to evaluate renal function (plasmatic creatinina for CDK EPI formula). This blood sample can also be used to confirm the positive Chagas' serology if no serology is available (indirect immunofluorescence and ELISA).\n\nTe participants presenting a symptomatic lower urinary tract dysfunction on the previous exams will be proposed a complete urodynamic exploration (cystomanometry, urethral profile, pression/flow study during mycturition).\n\nSterility of urine assessed before exam. Tecnical material imported from Spain, Albyn medical Smardyn and consummables. Electronic curves obtained from Phoenix software (Albyn).\n\nObjective inclusion of 200 participants during 5 months, between June and October 2017, in the SELADIS Institute in La Paz, Bolivia. Director of study Dr Simone Frédérique Brenière (french), Bolivian Director of Institute Dra Susana Revollo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting a chronic form of chagas disease diagnosed by the SELADIS institute (serology), by cardiology, gastro-enterology or infectious disease consultation in La Paz may be include, after the informed consent have been signed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between 18 and 50 years of age\n* Presenting a chronic form of Chagas disease : cardiopathy or enteropathy\n* Previously treated or not treated\n* Signed informed consent\n\nExclusion Criteria:\n\n* Diabetes\n* Neurologic pathology\n* Past history of extensive pelvic surgery\n* Vaginal prolaps \\> grade 3 of Baden \\& Walker (female)\n* Past history of vertebral fracture \\> L2'}, 'identificationModule': {'nctId': 'NCT03189056', 'briefTitle': "Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut de Recherche pour le Developpement'}, 'officialTitle': "Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation", 'orgStudyIdInfo': {'id': 'Chagas_urology'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single cohort', 'description': 'single cohort for transversal study patients presenting chronic chagas disease for all patients : clinical examination/questionnaires/ quality of life/ blood sample for renal function (creatinina) and Chagas serology control if needed/ uroflowmetry/ ultrasonography\n\nIf symptomatic patient at first exploration : urodynamic exploration is proposed (cystomanometry, urethral profile, pressure/flow study). No electromyograma. No video urodynamic procedure.', 'interventionNames': ['Diagnostic Test: Chagas serology', 'Biological: Creatinina', 'Procedure: Urodynamic exploration']}], 'interventions': [{'name': 'Chagas serology', 'type': 'DIAGNOSTIC_TEST', 'description': 'IFI + ELISA method if no biological confirmation of chagas disease is in our possession', 'armGroupLabels': ['Single cohort']}, {'name': 'Creatinina', 'type': 'BIOLOGICAL', 'description': 'Plasmatic single mesure after consultation 1, to evaluate renal function', 'armGroupLabels': ['Single cohort']}, {'name': 'Urodynamic exploration', 'type': 'PROCEDURE', 'description': 'With a new equipement SmartDyn Albynmedical imported from Spain for the study Single use sterile equipment shipped Control of urine sterility before procedure Informed consent signed If acquired urinary infection after procedure, patient treated free of charge and clinical evolution controlled', 'armGroupLabels': ['Single cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Paz', 'country': 'Bolivia', 'facility': 'SELADIS Institute, Universidad Mayor de San Andrès', 'geoPoint': {'lat': -16.5, 'lon': -68.15}}], 'overallOfficials': [{'name': 'Elsa BEY, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in urological surgery', 'investigatorFullName': 'Elsa BEY', 'investigatorAffiliation': 'Institut de Recherche pour le Developpement'}}}}