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Incontinence UrinaryNCT01891162

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

An observational study of Incontinence Urinary, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Incontinence Urinary
How many people
200 participants
Where
2 sitesBrazil
Study dates
Dec 2013to Jan 2015
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • postmenopausal women
  • clinical diagnosis of urinary incontinence and / or pelvic organ prolapse
  • without contraction uninhibited detrusor

Who cannot join

  • cognitive deficit
  • presence of uninhibited detrusor contraction

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites
  • Cesar cals hospital

    Fortaleza, Ceará, 60125120

  • General Hospital Fortaleza

    Fortaleza, Ceará, 60125120

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Keywords
quality of life, incontinence urinary, socioeconomic
Medical subject headings
Nocturnal Enuresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01891162
Study groupRoleWhat they receive
ControlAssessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT
StudyWill 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of socioeconomic status by Brazil and quality of life for urinary in Brazilian women

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionJan 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
200 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT01891162
Sponsor's protocol ID
ISADRI
Status last verified
Aug 2013
First submitted
8 Mar 2013
Last updated
2 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Incontinence Urinary, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of socioeconomic status by Brazil and quality of life for urinary in Brazilian women (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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