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OpenTrials
Completed

NCT Number: NCT01663181

Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. difference between anticipated pain and actual pain perception

    Time frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2012
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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