Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Study Overview
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Brief Summary
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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.

Official Title
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Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| urogynecologic patients undergoing outpatient cystoscopy<br> | |
| urogynecologic patients undergoing outpatient-urodynamics<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between anticipated pain and actual pain perception |  | immediately before and immediately after the examination (zero to ten minutes after undergoing examination) |