Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Completed

• Conditions: Overactive Bladder; Recurrent Urinary Tract Infections; Pelvic Organ Prolapse; Urinary Incontinence

• Registration Number: NCT01663181
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-02
• Study Completion: 2010-04
• Study First Submitted: 2012-08-05
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

• women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.

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Exclusion Criteria

• age ≤ 18 years
• insufficient ability to understand German
• pregnancy
• participation in another clinical study at the same time

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
subjective pain perception immediately after examination as measured by a standard visual analog scale	immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)	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

Secondary Outcome Measures

Name	Time	Method
difference between anticipated pain and actual pain perception	immediately before and immediately after the examination (zero to ten minutes after undergoing examination)

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria