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Urinary Incontinence in Women From Amapa (iuemcp)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jorge Milhem Haddad, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01933854
First received: June 18, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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
Urinary Incontinence

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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 380
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)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933854

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Jorge Milhem Haddad, Phd, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01933854     History of Changes
Other Study ID Numbers: 2012MACAPASP
Study First Received: June 18, 2013
Last Updated: August 28, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Urinary incontinence
riverside
women
Amapa

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014