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

Chagas' Disease (Chronic) With Other Organ Involvement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189056
• Other study ID #: Chagas_urology
• Status: Completed
• First received: June 9, 2017
• Last updated: March 26, 2018
• Start date: July 14, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: March 2018
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease
• Chagas' Disease (Chronic) With Other Organ Involvement

Intervention

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

Locations

Country	Name	City	State
Bolivia	SELADIS Institute, Universidad Mayor de San Andrès	La Paz

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Megabladder	Bladder capacity >600cc and <4 daily micturition	at consultation : 1 day (transversal study, the participant will not be followed)
Secondary	Mega ureter	Ultrasonographic dilatation of renal pelvis>20mm or of ureter >7mm	at consultation : 1 day (transversal study, the participant will not be followed)
Secondary	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)
Secondary	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)
Secondary	Renal insufficiency	CDK EPI<60 mL/mn	at consultation : 1 day (transversal study, the participant will not be followed)
Secondary	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)
Secondary	Urinary sphincter insufficiency	P max<30 cm H20 and stress urinary incontinence	at consultation : 1 day (transversal study, the participant will not be followed)
Secondary	Erectile dysfunction in males	IIEF5 <16	at consultation : 1 day (transversal study, the participant will not be followed)
Secondary	Hypofertility	oral assess by difficulty to obtain pregnancy >1 year	at consultation : 1 day (transversal study, the participant will not be followed)

External Links

•   Ardito et al. " Chronic Renal Impairment in Patients with Chagas Cardiomyopathy with Chronic Systolic Heart Failure: Prevalence and Prognostic Significance ". Inte
•   Barr et al. " Canine Chagas' Disease (American Trypanosomiasis) in North America ". Veterinary Clinics of North America: Small Animal Practice, Small Animal Parasites: Biology and Control, 39, n? 6 (novembre 2009): 1055-64. doi:10.1016/j.cvsm.2009.06
•   Boczko et al. " Trypanosoma Cruzi Infection Induced Changes in the Innervation, Structure and Function of the Murine Bladder ". The Journal of Urology 173, n
•   Cabrine-Santos et al. " Genitourinary Changes in Hamsters Infected and Reinfected with Trypanosoma Cruzi ". Memórias Do Insti
•   Carraro, A. A., R. A. Lopes, R. D. Ribeiro, et T. L. Lamano Carvalho. " The Male Reproductive Organs in the Chronic Phase of Experimental Chagas' Disease ". Angewandte Parasitologie 33, n? 1 (février 1992): 3-9.
•   DeFaria, C. R., J. M. De Rezende, et A. Rassi. " [Peripheral denervation in the various clinical forms of Chagas' disease] ". Arquivos De Neuro-Psiquiatria 46, n? 3 (septembre 1988): 225-37.
•   Jelicks, Linda A., et Herbert B. Tanowitz. " Advances in Imaging of Animal Models of Chagas Disease ". Advances in Parasitology 75 (2011): 193-208. doi:10.1016/B978-0-12-385863-4.00009-5.
•   Koeberle, F. " ENTEROMEGALY AND CARDIOMEGALY IN CHAGAS DISEASE ". Gut 4 (décembre 1963): 399-405.
•   Mirkin et al. " Experimental Chagas' Disease: Electrophysiology and Cell Composition of the Neuromyopathic Inflammatory Lesions in Mice Infected with a Myotropic and a Pantropic Strain of
•   Ny, Lars et al. " A Magnetic Resonance Imaging Study of Intestinal Dilation in Trypanosoma Cruzi-Infected Mice Deficient in Nitric Oxide Synthase ". The American Jour
•   Rocha, J. N., H. J. Suaid, A. C. P. Martins, A. J. Cologna, S. Tucci Jr., et M. A. Gonçalves. " URODYNAMIC ASSESSEMENT IN PATIENTS WITH CHAGAS DISEASE ". Acta Cirurgica Brasileira 16 (2001): 7-8. doi:10.1590/S0102-86502001000500003.
•   Said, G?rard, Mireille Joskowicz, Amilton Antunes Barreira, et Harvey Eisen. " Neuropathy Associated with Experimental Chagas' Disease ". Annals of Neurology 18, n? 6 (décembre 1985): 676-83. doi:10.1002/ana.410180609.
•   Scremin et al. " T.cruzi induces megabladder in experimental chagas disease ". Parasitology International 47, Supplement 1 (août 1998): 200. doi:10.1016/S1383-5769(98)80520-5.
•   Scremin, L. H., C. E. Corbett, M. D. Laurenti, E. V. Nunes, J. J. Gama-Rodrigues, et M. Okumura. " Megabladder in Experimental Chagas Disease: Pathological Features of the Bladder Wall ". Revista Do Hospital Das Clínicas 54, n? 2 (avril 1999): 43-46.
•   Suaid et al. " Modulation of Urethral Alpha-Sympathetic by Parasympathetic before and Following Bethanechol Chloride Injection ". International Braz J Urol: Official J