Clinical trial NCT01933854: Urinary Incontinence in Women From Amapa
Official title: ASSESSMENT OF URINARY INCONTINENCE IN WOMEN AT AMAPA STATE: COMPARISON BETWEEN URBAN AND RIVERSIDE POPULATIONS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
riverside
women
Amapa
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 380
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Urinary incontinence and life style (riverside population X urban population)
timeFrame: Thirteen months
Secondary outcomes:
Other outcomes:
Locations:
city: Macapa
country: Brazil
facility: Mae Luzia Women's Hospital
state: Amapa
Study officials:
affiliation: University of Sao Paulo
name: Aljerry Rego, Graduate
role: PRINCIPAL_INVESTIGATOR
References: