Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
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.
Pelvic Organ Prolapse
Recurrent Urinary Tract Infections
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study|
- subjective pain perception immediately after examination as measured by a standard visual analog scale [ Time Frame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics) ] [ Designated as safety issue: No ]
patients are assessed at three points in time:
- zero to ten minutes before undergoing examination
- zero to ten minutes after undergoing examination
- 24 hours after undergoing examination
- difference between anticipated pain and actual pain perception [ Time Frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination) ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|urogynecologic patients undergoing outpatient cystoscopy|
|urogynecologic patients undergoing outpatient-urodynamics|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663181
|Medical University Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Wolfgang Umek, Prof||Medical University Vienna Austria|