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| Name | Class |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | OTHER |
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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.
This 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.
Various 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.
Human 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.
The 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.
Epidemiologic observationnal transversal study
Cohort 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.
Recruitment via the existing patients list of positive Chagas serology of:
Informed consent signed.
1 to 3 consultations on a period of one to 2 weeks no follow-up (transversal study)
Invasive descriptive explorations (blood sample and urodynamic study, imposing the assent of the Comité Nacional de Bioética).
Main 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.
Secondary objectives :
All the included patients will be proposed an initial consult :
Te 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).
Sterility of urine assessed before exam. Tecnical material imported from Spain, Albyn medical Smardyn and consummables. Electronic curves obtained from Phoenix software (Albyn).
Objective 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cohort | 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 If symptomatic patient at first exploration : urodynamic exploration is proposed (cystomanometry, urethral profile, pressure/flow study). No electromyograma. No video urodynamic procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chagas serology | Diagnostic Test | IFI + ELISA method if no biological confirmation of chagas disease is in our possession |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic patients | ICIQ SF>0 IPSS>7 or past acute urinary retention IIEF5<11 | at consultation : 1 day (transversal study, the participant will not be followed) |
| Measure | Description | Time Frame |
|---|---|---|
| Megabladder | Bladder capacity >600cc and <4 daily micturition | at consultation : 1 day (transversal study, the participant will not be followed) |
| Mega ureter | Ultrasonographic dilatation of renal pelvis>20mm or of ureter >7mm |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Elsa BEY, Resident | IRD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SELADIS Institute, Universidad Mayor de San Andrès | La Paz | Bolivia |
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| Label | URL |
|---|---|
| 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. | View source |
| 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 | View source |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D003404 | Creatinine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Creatinina | Biological | Plasmatic single mesure after consultation 1, to evaluate renal function |
|
| Urodynamic exploration | Procedure | 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 |
|
| at consultation : 1 day (transversal study, the participant will not be followed) |
| Hyperactive bladder | >8 daily micturition + urgency on dairy subsection detrusor hyperactivity on cystomanometry | micturition calendar over 2 days (transversal study, the participant will not be followed) |
| Detrusor underactivity | Qmax<15 mL/s and post void residual>150cc per-micturition pressure <40 cm H2O | at consultation : 1 day (transversal study, the participant will not be followed) |
| Renal insufficiency | CDK EPI<60 mL/mn | at consultation : 1 day (transversal study, the participant will not be followed) |
| Urinary recurrent infections | 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 | reported infections duing the last 5 years (transversal study, the participant will not be followed) |
| Urinary sphincter insufficiency | P max<30 cm H20 and stress urinary incontinence | at consultation : 1 day (transversal study, the participant will not be followed) |
| Erectile dysfunction in males | IIEF5 <16 | at consultation : 1 day (transversal study, the participant will not be followed) |
| Hypofertility | oral assess by difficulty to obtain pregnancy >1 year | at consultation : 1 day (transversal study, the participant will not be followed) |
| Ardito et al. " Chronic Renal Impairment in Patients with Chagas Cardiomyopathy with Chronic Systolic Heart Failure: Prevalence and Prognostic Significance ". Inte | View source |
| Koeberle, F. " ENTEROMEGALY AND CARDIOMEGALY IN CHAGAS DISEASE ". Gut 4 (décembre 1963): 399-405. | View source |
| 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 | View source |
| Cabrine-Santos et al. " Genitourinary Changes in Hamsters Infected and Reinfected with Trypanosoma Cruzi ". Memórias Do Insti | View source |
| 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. | View source |
| Suaid et al. " Modulation of Urethral Alpha-Sympathetic by Parasympathetic before and Following Bethanechol Chloride Injection ". International Braz J Urol: Official J | View source |
| 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. | View source |
| 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. | View source |
| 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. | View source |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |