Assessment of Socioeconomic Status by Brazil and Quality of Life for Urinary Incontinence in Brazilian Women

NCT ID: NCT01891162

Last Updated: 2013-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Incontinence Urinary

Keywords

quality of life, incontinence urinary, socioeconomic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

Assessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ISABELLA P FROTA

Role: PRINCIPAL_INVESTIGATOR

Pesquisadora

Locations

Cesar cals hospital

Fortaleza, Ceará, Brazil

General Hospital Fortaleza

Fortaleza, Ceará, Brazil

Countries

Brazil

Other Identifiers

ISADRI

Identifier Type: -

Identifier Source: org_study_id