- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891162
Assessment of Socioeconomic Status by Brazil and Quality of Life for Urinary Incontinence in Brazilian Women
August 30, 2013 updated by: University of Sao Paulo General Hospital
Socioeconomic Profile and QUALITY OF LIFE FOR WOMEN WITH AND WITHOUT PELVIC FLOOR DYSFUNCTION
Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk factors for female urinary incontinence and pelvic organ prolapse at the population level.
The socioeconomic risks for incontinence have however, conflicting evidence with assorted measures of socioeconomic status.
Brazil is a country with enormous social contrasts, and deep inequality.
We have a mixed origin of cultures and different economic and regional conditions.
We believe that the perception and the impact that has Pelvic floor dysfunction in the quality of life of the woman must vary widely according to socioeconomic status (including household income, highest educational level, family income).
There is to date no studies have correlated a criterion for classifying economic official in Brazil with the impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and pelvic organ prolapse.
Study Overview
Status
Unknown
Conditions
Detailed Description
The research is being conducted at the Department of Gynecology of a referral hospital in the state of Ceará, Brazil in the period October 2011 to February 2012.
Women will be referred from Primary Care and Health scheduled for evaluation in the sector of Urogynecology Cesar Cals General Hospital, Department of Health of the State of Ceará.
During the study period 200 patients will be treated with complaints of urinary incontinence or pelvic organ prolapse in the sector.
Included in the study women who were postmenopausal, who are not taking hormone therapy in the last six months.
Women with urinary loss, which does not have non-inhibited contraction of the detrusor proven by urodynamic study.
Will be compared with a group of women without pelvic floor dysfunction confirmed by clinical history and gynecological examination with the same characteristics in relation to postmenopausal status, all from the general gynecology outpatient clinic.
Will be used for data collection socioeconomics an interview administrated questionnaire adapted from the Brazil Economic Classification Criterion - 2011 (CCEB) The CCEB is an instrument of economic segmentation that uses the survey of household characteristics (presence and quantity of some items of comfort and home schooling level of household head) to differentiate the population.
The criterion assigns points according to each household characteristic and performs the sum of these points.
Then will be made a match score of the test strips and layers of economic status defined by A1, A2, B1, B2, C1, C2, D, E. This criterion was designed to define broad classes that meet the needs of segmentation (by purchasing power) of most companies.
To evaluate Quality of Life in Urinary incontinence and pelvic organ prolapse women we used the KHQ questionnaire, QoL-P respectively.
To evaluate the Overall Quality of Life, SF-36.
For functional evaluation of the pelvic floor (AP) bidigital evaluation was performed using the classification of Ortiz (1996) and schema PERFECT Oxford (1990).
Will be used the application EpiInfo version 6.04, Atlanta, USA.
Will be studied the socioeconomic variables (age, educational level, economic status and income), health perception variables (the impact of incontinence / prolapse, the limitations of performance tasks, physical limitation, social limitation, personal relationships, the emotions, sleep and energy and gravity measurements).
Will be used the prevalence of urinary incontinence as a measure of the occurrence and chi-square test and test of Pearson to evaluate the statistical significance considering p <0.05.
Exploratory analysis will also performed to describe the frequency distribution of socioeconomic variables.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ce
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Fortaleza, Ce, Brazil, 60125120
- Cesar cals hospital
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Fortaleza, Ce, Brazil, 60125120
- General Hospital Fortaleza
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
will be avalueted women who will be postmenopausal, who are not taking hormone therapy in the last six months.
Women with urinary loss, which does not have non-inhibited contraction of the detrusor proven by urodynamic study.
Will be compared with a group of women without pelvic floor dysfunction confirmed by clinical history and gynecological examination with the same characteristics in relation to postmenopausal status, all from the general gynecology outpatient clinic.
Description
Inclusion Criteria:
- postmenopausal women
- clinical diagnosis of urinary incontinence and / or pelvic organ prolapse
- without contraction uninhibited detrusor
Exclusion Criteria:
- cognitive deficit
- presence of uninhibited detrusor contraction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
Assessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT
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Study
Will be held evaluate the quality of life for general and specific pelvic floor dysfunction beyond the functional assessment of the pelvic floor through the PERFECT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of socioeconomic status by Brazil and quality of life for urinary in Brazilian women
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ISABELLA P FROTA, Pesquisadora
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2014
Study Completion (ANTICIPATED)
January 1, 2015
Study Registration Dates
First Submitted
March 8, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (ESTIMATE)
July 2, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2013
Last Update Submitted That Met QC Criteria
August 30, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- ISADRI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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