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临床试验/NCT03189056
NCT03189056已完成不适用

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

Institut de Recherche pour le Developpement1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2017年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
1
主要终点
Symptomatic patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Neurologic pathology
  • Past history of extensive pelvic surgery
  • Vaginal prolaps > grade 3 of Baden & Walker (female)
  • Past history of vertebral fracture > L2

结局指标

主要结局

Symptomatic patients

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

ICIQ SF\>0 IPSS\>7 or past acute urinary retention IIEF5\<11

次要结局

  • Megabladder(at consultation : 1 day (transversal study, the participant will not be followed))
  • Hyperactive bladder(micturition calendar over 2 days (transversal study, the participant will not be followed))
  • Urinary sphincter insufficiency(at consultation : 1 day (transversal study, the participant will not be followed))
  • Detrusor underactivity(at consultation : 1 day (transversal study, the participant will not be followed))
  • Renal insufficiency(at consultation : 1 day (transversal study, the participant will not be followed))
  • Urinary recurrent infections(reported infections duing the last 5 years (transversal study, the participant will not be followed))
  • Hypofertility(at consultation : 1 day (transversal study, the participant will not be followed))
  • Mega ureter(at consultation : 1 day (transversal study, the participant will not be followed))
  • Erectile dysfunction in males(at consultation : 1 day (transversal study, the participant will not be followed))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elsa BEY

Resident in urological surgery

Institut de Recherche pour le Developpement

研究点 (1)

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