iuemcp: Urinary Incontinence in Women From Amapa

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01933854
Collaborator
(none)
380
1
12
31.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    380 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ASSESSMENT OF URINARY INCONTINENCE IN WOMEN AT AMAPA STATE: COMPARISON BETWEEN URBAN AND RIVERSIDE POPULATIONS
    Study Start Date :
    Feb 1, 2013
    Anticipated Primary Completion Date :
    Sep 1, 2013
    Anticipated Study Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Riverside group

    Women aged 20 years or over who are not pregnant living riverside area of the Amapa State Brazil.

    urban group

    women aged 20years or over not pregnant and living urban area

    Outcome Measures

    Primary Outcome Measures

    1. Urinary incontinence and life style (riverside population X urban population) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • women aged 20 or over

    • living either in the urban area or in the riverside

    Exclusion Criteria:
    • women under 20 and

    • pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mae Luzia Women's Hospital Macapa Amapa Brazil 68900-000

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    • Principal Investigator: Aljerry Rego, Graduate, University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jorge Milhem Haddad, Phd, University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT01933854
    Other Study ID Numbers:
    • 2012MACAPASP
    First Posted:
    Sep 2, 2013
    Last Update Posted:
    Sep 2, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Jorge Milhem Haddad, Phd, University of Sao Paulo General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 2, 2013