An observational study in Urinary Incontinence, Overactive Bladder and Pelvic Organ Prolapse, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Medical University of Vienna · Observational
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's enrollment of 109 is below the median of 200 across 188 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
women, aged >= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a tertiary referral center for urogynecologic conditions
Exclusion Criteria:
subjective pain perception immediately after examination as measured by a standard visual analog scale
patients are assessed at three points in time: 1. zero to ten minutes before undergoing examination 2. zero to ten minutes after undergoing examination 3. 24 hours after undergoing examination
Time frame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
difference between anticipated pain and actual pain perception
Time frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna