NCT01933854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

7 months

First QC Date

June 18, 2013

Last Update Submit

August 28, 2013

Conditions

Keywords

Urinary incontinenceriversidewomenAmapa

Outcome Measures

Primary Outcomes (1)

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

    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.

    Thirteen months

Study Arms (2)

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

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • women under 20 and
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mae Luzia Women's Hospital

Macapá, Amapá, 68900-000, Brazil

Location

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.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aljerry Rego, Graduate

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

June 18, 2013

First Posted

September 2, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

February 1, 2014

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations