Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01891162 |
| Other study ID # |
ISADRI |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
March 8, 2013 |
| Last updated |
August 30, 2013 |
| Start date |
December 2013 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
August 2013 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ethics Committee |
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
