Urinary Incontinence in Women From Amapa

NCT ID: NCT01933854

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Keywords

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Urinary incontinence riverside women Amapa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Riverside group

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

No interventions assigned to this group

urban group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* women under 20 and
* pregnant
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jorge Milhem Haddad

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aljerry Rego, Graduate

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Mae Luzia Women's Hospital

Macapá, Amapá, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2012MACAPASP

Identifier Type: -

Identifier Source: org_study_id