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临床试验/NCT01933854
NCT01933854Unknown不适用

ASSESSMENT OF URINARY INCONTINENCE IN WOMEN AT AMAPA STATE: COMPARISON BETWEEN URBAN AND RIVERSIDE POPULATIONS

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
380
试验地点
1
主要终点
Urinary incontinence and life style (riverside population X urban population)

研究概览

简要总结

The investigators aim to study the prevalence of urinary incontinence in women who live in the riverside community in the state of Amapa (The Bailique Island) and compare it to the prevalence of urinary incontinence in women who live in the urban region -Macapa-the capital city of the Amapa State - Brazil.

详细描述

The study aims to compare urinary complaints of women belonging to two different groups: women who live in a riverside area of the Amapa State-the Bailique Island, which is about 12 hours by boat from the state capital city and compare them to those of the women who live in the urban region -Macapa (the capital city of the Amapa State). The main goals are: to describe the clinical features of the women in the study, assess probable risk factors concerning the urinary incontinence, make physical gynecological exam as well as urodynamic studies in the patients who have urinary complaints and use a life quality questionnaire with those patients (Kings Health Questionnaire).

Cross and prevalence Study, followed by case series. Cohort study between the two populations. The riverside group with 120 interviews and the urban group with 260 interviews, where the sample calculation was based on the population of each region and the incidence of urinary incontinence checked through a pilot study.

After reading and signing an informed consent, interviews with women aged 20 years or over and non-pregnant are hold so as to identify those who have complaints about urinary incontinence, socio-economic data and risk factors. In patients who complain about urinary incontinence, gynecological exams are performed in order to assess genital prolapse and urodynamic studies are made as to confirm urinary incontinence and life quality questionnaire. All the data will be encoded in the database and analyzed through statistics programs and a comparison between the two groups (urban and riverside) will be made.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 20 or over
  • living either in the urban area or in the riverside

排除标准

  • women under 20 and

结局指标

主要结局

Urinary incontinence and life style (riverside population X urban population)

时间窗: Thirteen months

Assessment of urinary incontinence in women who live in a riverside community and who have had a home dilivery when compared with women from urban community. They will be assessed through the use of a questionnaire of quality of life and urodynamic evaluation.

次要结局

未报告次要终点

研究者

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

Jorge Milhem Haddad

Phd

University of Sao Paulo General Hospital

研究点 (1)

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