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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00939432
Other study ID # EK 453/2008
Secondary ID
Status Completed
Phase N/A
First received July 14, 2009
Last updated July 14, 2009
Start date November 2005
Est. completion date April 2007

Study information

Verified date July 2009
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Medical University of Vienna, Institutional Review Board
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 2007
Est. primary completion date April 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects older than 18 years willing to take part in study mentally capable to understand and fill in anonymous questionnaire

Exclusion Criteria:

- incomplete questionnaire

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Locations

Country Name City State
Austria Medical University of Vienna Austria Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perception of given medical condition as a taboo issue single point in time No
Secondary Knowledge of treatment options of incontinence single point in time No
Secondary Knowledge of friends or relatives with incontinence single point in time No
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