Urinary Incontinence AwarenessNCT00939432
Taboo Perception of Incontinence, Depression and Cancer
An observational study of Urinary Incontinence Awareness and Gender Differences, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Objective/study hypothesis To evaluate how much of a taboo UI is and how it compares to other medical conditions that may also pose a taboo issue like depression and cancer. Background Urinary incontinence (UI) is a highly prevalent condition with more than 200 million people worldwide being affected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence Awareness, Gender Differences
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2005to Apr 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of 150 test persons from waiting areas of a teaching hospital and in private practices of general practitioners in Austria agreed to take part in the study, with an additional 10 persons (6.2%) declining after being informed about the subject.
Who may be able to join
- Subjects older than 18 years willing to take part in study mentally capable to understand and fill in anonymous questionnaire
Who cannot join
- incomplete questionnaire
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna Austria
Vienna, State of Vienna, 1090
About this study
Official title: The Greatest Taboo- Urinary Incontinence, Depression and Cancer
Objective/study hypothesis To evaluate how much of a taboo UI is and how it compares to other medical conditions that may also pose a taboo issue like depression and cancer.
Background Urinary incontinence (UI) is a highly prevalent condition with more than 200 million people worldwide being affected. While physical health does not necessarily have to be impaired much, restriction of social activities leads to isolation, a significant reduction in quality of life and will often bring about subsequent morbidity. Despite its prevalence, many patients suffering from UI go undiagnosed and untreated. Patients often hesitate to report the problem, and health care professionals often do not ask about it. In a study Minassian (2003) estimated that just one in four patients actively seeks medical attention. The reason for this may lie in the shame, embarrassment, and stigma associated with this condition, which in turn pose significant barriers to seeking professional treatment. Although mentioned by many narrative reviews and included in some epidemiological papers on UI, surprisingly we found no data addressing the taboo of UI exclusively. The aim of our study therefore was
Methods/Design A 13-question self-administered questionnaire was developed and face validity tested by 2 of the authors (KH, EH). The anonymous questionnaire contained simple questions on gender and age and then asked yes/no questions on whether test persons knew people with UI, or suspected other people to be incontinent, if they would address this issue with the suspected person, and if they thought that UI was a taboo issue in the society. On a scale from 0 - 10 they were then asked to grade the amount of embarrassment and anxiety if they themselves were incontinent, compared to depression or cancer. A few questions on knowledge of the condition of UI and to whom test persons would turn to in case of UI concluded the short questionnaire, which took about 5 minutes to fill in. A convenience sample of 150 test persons from waiting areas of a teaching hospital and in private practices of general practitioners in Austria agreed to take part in the study, with an additional 10 persons (6.2%) declining after being informed about the subject. Data were analysed with the SPSS 10.0.5 software package using the U-test, Chi-square-test, Yates-correction, Fisher's exact test and Kolmogorov-Smirnov normality test where appropriate.
- Conditions
- Urinary Incontinence Awareness, Gender Differences
- Keywords
- incontinence, urinary, taboo, shame, embarrassment, treatment, depression, cancer
- Medical subject headings
- Depression, Neoplasms
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 |
|---|---|---|
| Gender | male/female | |
| Age | 18-100 years | |
| Educational level | primary school, secondary school, university |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of given medical condition as a taboo issue
Measured: single point in time
Secondary outcomes (2)
Knowledge of treatment options of incontinence
Measured: single point in time
Knowledge of friends or relatives with incontinence
Measured: single point in time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startNov 2005
- Primary completionApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence AwarenessStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939432
- Sponsor's protocol ID
- EK 453/2008
- Status last verified
- Jul 2009
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Greatest Taboo- Urinary Incontinence, Depression and Cancer
- ClinicalTrials.gov ID
- NCT00939432
- Acronym / sponsor ID
- EK 453/2008
- Conditions
- Urinary Incontinence Awareness, Gender Differences
- Keywords
- incontinence, urinary, taboo, shame, embarrassment, treatment, depression, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Jul 2009 (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.
Objective/study hypothesis To evaluate how much of a taboo UI is and how it compares to other medical conditions that may also pose a taboo issue like depression and cancer.
Background Urinary incontinence (UI) is a highly prevalent condition with more than 200 million people worldwide being affected. While physical health does not necessarily have to be impaired much, restriction of social activities leads to isolation, a significant reduction in quality of life and will often bring about subsequent morbidity. Despite its prevalence, many patients suffering from UI go undiagnosed and untreated. Patients often hesitate to report the problem, and health care professionals often do not ask about it. In a study Minassian (2003) estimated that just one in four patients actively seeks medical attention. The reason for this may lie in the shame, embarrassment, and stigma associated with this condition, which in turn pose significant barriers to seeking professional treatment. Although mentioned by many narrative reviews and included in some epidemiological papers on UI, surprisingly we found no data addressing the taboo of UI exclusively. The aim of our study therefore was
Methods/Design A 13-question self-administered questionnaire was developed and face validity tested by 2 of the authors (KH, EH). The anonymous questionnaire contained simple questions on gender and age and then asked yes/no questions on whether test persons knew people with UI, or suspected other people to be incontinent, if they would address this issue with the suspected person, and if they thought that UI was a taboo issue in the society. On a scale from 0 - 10 they were then asked to grade the amount of embarrassment and anxiety if they themselves were incontinent, compared to depression or cancer. A few questions on knowledge of the condition of UI and to whom test persons would turn to in case of UI concluded the short questionnaire, which took about 5 minutes to fill in. A convenience sample of 150 test persons from waiting areas of a teaching hospital and in private practices of general practitioners in Austria agreed to take part in the study, with an additional 10 persons (6.2%) declining after being informed about the subject. Data were analysed with the SPSS 10.0.5 software package using the U-test, Chi-square-test, Yates-correction, Fisher's exact test and Kolmogorov-Smirnov normality test where appropriate.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gender | – | –male/female |
| Age | – | –18-100 years |
| Educational level | – | –primary school, secondary school, university |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of 150 test persons from waiting areas of a teaching hospital and in private practices of general practitioners in Austria agreed to take part in the study, with an additional 10 persons (6.2%) declining after being informed about the subject.
Key inclusion criteria (1 listed)
- Subjects older than 18 years willing to take part in study mentally capable to understand and fill in anonymous questionnaire
Key exclusion criteria (1 listed)
- incomplete questionnaire
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
Perception of given medical condition as a taboo issue
Time frame: single point in time
2 secondary outcomes
Knowledge of treatment options of incontinence
Time frame: single point in time
Knowledge of friends or relatives with incontinence
Time frame: single point in time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
Related trials for Urinary Incontinence Awareness
Not yet recruitingObservational study
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Stress Urinary Incontinence (SUI)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence Awareness and Gender Differences, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perception of given medical condition as a taboo issue (time frame: single point in time). 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 15 Jul 2009.