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NCT Number: NCT03189056

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

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.

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Key information

Conditions

Chagas' Disease (Chronic) With Other Organ Involvement Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chagas Disease Euglenozoa Infections Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Parasitic Diseases Protozoan Infections Respiratory Tract Diseases Trypanosomiasis Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SELADIS Institute, Universidad Mayor de San Andrès

La Paz, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chagas serology

Diagnostic Test

IFI + ELISA method if no biological confirmation of chagas disease is in our possession

Creatinina

Biological

Plasmatic single mesure after consultation 1, to evaluate renal function

Urodynamic exploration

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Megabladder

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    Bladder capacity >600cc and <4 daily micturition

  2. Mega ureter

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    Ultrasonographic dilatation of renal pelvis>20mm or of ureter >7mm

  3. Hyperactive bladder

    Time frame: micturition calendar over 2 days (transversal study, the participant will not be followed)

    >8 daily micturition + urgency on dairy subsection detrusor hyperactivity on cystomanometry

  4. Detrusor underactivity

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    Qmax<15 mL/s and post void residual>150cc per-micturition pressure <40 cm H2O

  5. Renal insufficiency

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    CDK EPI<60 mL/mn

  6. Urinary recurrent infections

    Time frame: reported infections duing the last 5 years (transversal study, the participant will not be followed)

    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

  7. Urinary sphincter insufficiency

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    P max<30 cm H20 and stress urinary incontinence

  8. Erectile dysfunction in males

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    IIEF5 <16

  9. Hypofertility

    Time frame: at consultation : 1 day (transversal study, the participant will not be followed)

    oral assess by difficulty to obtain pregnancy >1 year

Sponsors and collaborators

Lead sponsor

Institut de Recherche pour le Developpement

Other Gov

Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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