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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chagas' Disease (Chronic) With Other Organ Involvement

Intervention / Treatment
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* Diagnostic Test: Chagas serology
* Biological: Creatinina
* Procedure: Urodynamic exploration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single cohort<br>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. | Diagnostic Test: Chagas serology<br>* IFI + ELISA method if no biological confirmation of chagas disease is in our possession<br>Biological: Creatinina<br>* Plasmatic single mesure after consultation 1, to evaluate renal function<br>Procedure: Urodynamic exploration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder, chronic Chagas disease, lower urinary tract, urodynamic