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At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health. The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing. According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05. Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Medical University Vienna
Vienna, Austria
Start Date
May 1, 2009
Primary Completion Date
February 1, 2010
Completion Date
April 1, 2010
Last Updated
April 12, 2022
109
ACTUAL participants
Lead Sponsor
Medical University of Vienna
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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