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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01663181
Other study ID # 413/2009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2009
Est. completion date April 2010

Study information

Verified date April 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date April 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center. Exclusion Criteria: - age = 18 years - insufficient ability to understand German - pregnancy - participation in another clinical study at the same time

Study Design


Locations

Country Name City State
Austria Medical University Vienna 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 subjective pain perception immediately after examination as measured by a standard visual analog scale 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
immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
Secondary difference between anticipated pain and actual pain perception immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
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