An observational study in Chagas' Disease (Chronic) With Other Organ Involvement, sponsored by Institut de Recherche pour le Developpement. Completed at 1 site in Bolivia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Institut de Recherche pour le Developpement · Observational
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.
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:
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 :
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.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
This study's enrollment of 152 is above the median of 120 across 21 observational studies indexed under Chagas Disease.
Browse Chagas Disease studies →Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Biological: Creatinina · Procedure: Urodynamic exploration
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
Symptomatic patients
ICIQ SF\>0 IPSS\>7 or past acute urinary retention IIEF5\<11
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Megabladder
Bladder capacity \>600cc and \<4 daily micturition
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Mega ureter
Ultrasonographic dilatation of renal pelvis\>20mm or of ureter \>7mm
Time frame: 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
Time frame: 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
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Renal insufficiency
CDK EPI\<60 mL/mn
Time frame: 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
Time frame: 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
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Erectile dysfunction in males
IIEF5 \<16
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Hypofertility
oral assess by difficulty to obtain pregnancy \>1 year
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Plan to share: No
Ran from Jul 2017 to primary completion in Oct 2017, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut de Recherche pour le Developpement