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.
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
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.
- Conditions
- Incontinence Urinary
- 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 group | Role | What they receive |
|---|---|---|
| Control | Assessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted2 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence UrinaryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ISABELLA P FROTA, Principal investigator, Pesquisadora
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Profile and QUALITY OF LIFE FOR WOMEN WITH AND WITHOUT PELVIC FLOOR DYSFUNCTION
- ClinicalTrials.gov ID
- NCT01891162
- Acronym / sponsor ID
- ISADRI
- Conditions
- Incontinence Urinary
- Keywords
- quality of life, incontinence urinary, socioeconomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Assessment will be carried out general quality of life beyond the functional evaluation of the pelvic floor through the PERFECT |
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- postmenopausal women
- clinical diagnosis of urinary incontinence and / or pelvic organ prolapse
- without contraction uninhibited detrusor
Key exclusion criteria (2 listed)
- cognitive deficit
- presence of uninhibited detrusor contraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of socioeconomic status by Brazil and quality of life for urinary in Brazilian women
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ISABELLA P FROTA principal investigator
Pesquisadora
2 sites in 1 country: see every site and its status.
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.