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Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation

NCT03189056 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2018-03-29

No results posted yet for this study

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.

Conditions

  • Chagas' Disease (Chronic) With Other Organ Involvement

Interventions

DIAGNOSTIC_TEST

Chagas serology

IFI + ELISA method if no biological confirmation of chagas disease is in our possession

BIOLOGICAL

Creatinina

Plasmatic single mesure after consultation 1, to evaluate renal function

PROCEDURE

Urodynamic exploration

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

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    collaborator OTHER

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Elsa BEY, Resident · IRD

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2017-10-20
Completion
2017-10-20

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189056 on ClinicalTrials.gov