Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
Condition: Chagas' Disease (Chronic) With Other Organ Involvement
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Chagas serology; Creatinina; Urodynamic exploration
Intervention type(s): Diagnostic Test; Biological; Procedure
Intervention description(s): IFI + ELISA method if no biological confirmation of chagas disease is in our possession; Plasmatic single mesure after consultation 1, to evaluate renal function; 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
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: chronic Chagas disease; bladder; lower urinary tract; urodynamic