Clinical trial NCT03189056: Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
Official title: Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas' Disease (Chronic) With Other Organ Involvement
Keywords: chronic Chagas disease
bladder
lower urinary tract
urodynamic
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Investigación Hospital Universitario La Paz
First posted: 2017-06-16
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 50 years of age
* Presenting a chronic form of Chagas disease : cardiopathy or enteropathy
* Previously treated or not treated
* Signed informed consent

Exclusion Criteria:

* Diabetes
* Neurologic pathology
* Past history of extensive pelvic surgery
* Vaginal prolaps \> grade 3 of Baden \& Walker (female)
* Past history of vertebral fracture \> L2

Primary outcomes:
measure: Symptomatic patients
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
Secondary outcomes:
measure: Megabladder
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Mega ureter
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Hyperactive bladder
timeFrame: micturition calendar over 2 days (transversal study, the participant will not be followed)
measure: Detrusor underactivity
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Renal insufficiency
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Urinary recurrent infections
timeFrame: reported infections duing the last 5 years (transversal study, the participant will not be followed)
measure: Urinary sphincter insufficiency
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Erectile dysfunction in males
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
measure: Hypofertility
timeFrame: at consultation : 1 day (transversal study, the participant will not be followed)
Other outcomes:
Locations:
city: La Paz
country: Bolivia
facility: SELADIS Institute, Universidad Mayor de San Andrès
Study officials:
affiliation: IRD
name: Elsa BEY, Resident
role: PRINCIPAL_INVESTIGATOR
References: