Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
|ClinicalTrials.gov Identifier: NCT01663181|
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : August 11, 2016
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.
|Condition or disease|
|Urinary Incontinence Overactive Bladder Pelvic Organ Prolapse Recurrent Urinary Tract Infections|
|Study Type :||Observational|
|Actual Enrollment :||109 participants|
|Official Title:||Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study|
|Study Start Date :||May 2009|
|Primary Completion Date :||February 2010|
|Study Completion Date :||April 2010|
|urogynecologic patients undergoing outpatient cystoscopy|
|urogynecologic patients undergoing outpatient-urodynamics|
- 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) ]
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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663181
|Medical University Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Wolfgang Umek, Prof||Medical University Vienna Austria|