Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Urinary Incontinence Clinical Trial

Official title:

Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663181
• Other study ID #: 413/2009
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Overactive Bladder
• Pelvic Organ Prolapse
• Prolapse
• Recurrent Urinary Tract Infections
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Tract Infections

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)