Chagas' Disease (Chronic) With Other Organ InvolvementNCT03189056
Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
An observational study of Chagas' Disease (Chronic) With Other Organ Involvement, run by Institut de Recherche pour le Developpement at 1 site in Bolivia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chagas' Disease (Chronic) With Other Organ Involvement
- What is being tested?
- Chagas serology, Creatinina and Urodynamic exploration
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteBolivia
- Study dates
- 14 Jul 2017to 20 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Diabetes
- Neurologic pathology
- Past history of extensive pelvic surgery
- Vaginal prolaps > grade 3 of Baden \& Walker (female)
- Past history of vertebral fracture > L2
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Chagas serology, Creatinina, Urodynamic exploration
- Keywords
- chronic Chagas disease, bladder, lower urinary tract, urodynamic
- Medical subject headings
- Chagas Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chagas serologyDiagnostic test
IFI + ELISA method if no biological confirmation of chagas disease is in our possession
CreatininaBiological
Plasmatic single mesure after consultation 1, to evaluate renal function
Urodynamic explorationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | 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. Receives: Diagnostic Test: Chagas serology; Biological: Creatinina; Procedure: Urodynamic exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic patients
ICIQ SF>0 IPSS>7 or past acute urinary retention IIEF5<11
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Secondary outcomes (9)
Megabladder
Bladder capacity >600cc and <4 daily micturition
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Mega ureter
Ultrasonographic dilatation of renal pelvis>20mm or of ureter >7mm
Measured: 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
Measured: 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
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Renal insufficiency
CDK EPI<60 mL/mn
Measured: 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
Measured: 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
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Erectile dysfunction in males
IIEF5 <16
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Hypofertility
oral assess by difficulty to obtain pregnancy >1 year
Measured: at consultation : 1 day (transversal study, the participant will not be followed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start14 Jul 2017
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas' Disease (Chronic) With Other Organ InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Responsible party
- Principal investigator, Elsa BEY, Institut de Recherche pour le Developpement
- Investigators
- Elsa BEY, Resident, Principal investigator, IRD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189056
- Sponsor's protocol ID
- Chagas_urology
- Status last verified
- Mar 2018
- First submitted
- 9 Jun 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Dysfunction in Chronic Chagas' Disease : Clinical and Urodynamic Presentation
- ClinicalTrials.gov ID
- NCT03189056
- Acronym / sponsor ID
- Chagas_urology
- Keywords
- chronic Chagas disease, bladder, lower urinary tract, urodynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | Diagnostic Test: Chagas serology, Biological: Creatinina, Procedure: Urodynamic explorationsingle 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Diabetes
- Neurologic pathology
- Past history of extensive pelvic surgery
- Vaginal prolaps > grade 3 of Baden \& Walker (female)
- Past history of vertebral fracture > L2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chagas serologyIFI + ELISA method if no biological confirmation of chagas disease is in our possession | Diagnostic test | Single cohort |
| CreatininaPlasmatic single mesure after consultation 1, to evaluate renal function | Biological | Single cohort |
| Urodynamic explorationWith 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 | Procedure or surgery | Single cohort |
Primary outcome
Symptomatic patients
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
ICIQ SF>0 IPSS>7 or past acute urinary retention IIEF5<11
9 secondary outcomes
Megabladder
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Mega ureter
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Hyperactive bladder
Time frame: micturition calendar over 2 days (transversal study, the participant will not be followed)
Detrusor underactivity
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Renal insufficiency
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Urinary recurrent infections
Time frame: reported infections duing the last 5 years (transversal study, the participant will not be followed)
Urinary sphincter insufficiency
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Erectile dysfunction in males
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Hypofertility
Time frame: at consultation : 1 day (transversal study, the participant will not be followed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- 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.Link provided by the sponsor.
- Ny, Lars et al. " A Magnetic Resonance Imaging Study of Intestinal Dilation in Trypanosoma Cruzi-Infected Mice Deficient in Nitric Oxide Synthase ". The American JourLink provided by the sponsor.
- Ardito et al. " Chronic Renal Impairment in Patients with Chagas Cardiomyopathy with Chronic Systolic Heart Failure: Prevalence and Prognostic Significance ". InteLink provided by the sponsor.
- Koeberle, F. " ENTEROMEGALY AND CARDIOMEGALY IN CHAGAS DISEASE ". Gut 4 (décembre 1963): 399-405.Link provided by the sponsor.
- 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 ofLink provided by the sponsor.
- Cabrine-Santos et al. " Genitourinary Changes in Hamsters Infected and Reinfected with Trypanosoma Cruzi ". Memórias Do InstiLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsa BEY, Resident principal investigator
IRD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas' Disease (Chronic) With Other Organ Involvement, run by Institut de Recherche pour le Developpement at 1 site in Bolivia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic patients (time frame: at consultation : 1 day (transversal study, the participant will not be followed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.