Chagas' Disease (Chronic) With Other Organ Involvement Clinical Trial
Official title:
Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
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:
- the SELADIS center (Instituto de Servicios de Laboratorio de Diagnostico e Investigacion
en Salud UMSA -UNIVERSIDAD MAYOR DE SAN ANDRES-)
- Private surrounding hospitals, Hospital de Clinicas and Centro de Seguro Social
Universitario de La Paz (UMSA)
- Laboratorio de Inmunodiagnostico Instituto Boliviano de Biologia de la Altura -IBBA-Dr
Lourdes Echalar.
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 :
- Anonymization of all the observation/results
- Past history (pathology, actual treatment,…), search of the exclusion criteria, Chagas'
disease symptomatology and treatment, urological symptomatology.
- Validated questionnaires to evaluate urological symptoms, urinary incontinence, voiding
dysfunction or acute urinary dysfunction, bladder hyperactivity, sexuality and
fertility.
- Clinical examination
- Micturition calendar /48hours.
- Uroflowmetry, followed by ultrasonography for post-void residual and upper-urinary tract
dilatation.
- 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).
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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