Urinary Incontinence in Women From Amapa (iuemcp)
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Days|
|Official Title:||ASSESSMENT OF URINARY INCONTINENCE IN WOMEN AT AMAPA STATE: COMPARISON BETWEEN URBAN AND RIVERSIDE POPULATIONS|
- Urinary incontinence and life style (riverside population X urban population) [ Time Frame: Thirteen months ] [ Designated as safety issue: Yes ]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.
Biospecimen Retention: None Retained
Urban group: women aged 20 years or over, who are not pregnant and are looking for a health facility to perform womb cancer prevention exam in Macapa, the capital city of the Amapa State.
Riverside Group: Women aged 20 years or over, who are not pregnant and are looking for a health facility to perform womb cancer prevention exam on the Bailique Island.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Women aged 20 years or over who are not pregnant living riverside area of the Amapa State Brazil.
women aged 20years or over not pregnant and living urban area
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933854
|Mae Luzia Women's Hospital|
|Macapa, Amapa, Brazil, 68900-000|
|Principal Investigator:||Aljerry Rego, Graduate||University of Sao Paulo|