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Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

This study has been completed.
Information provided by (Responsible Party):
Wolfgang Umek, MD, Medical University of Vienna Identifier:
First received: August 5, 2012
Last updated: August 10, 2016
Last verified: August 2016

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.

Urinary Incontinence
Overactive Bladder
Pelvic Organ Prolapse
Recurrent Urinary Tract Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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:

    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:
  • difference between anticipated pain and actual pain perception [ Time Frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination) ]

Enrollment: 109
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
urogynecologic patients undergoing outpatient cystoscopy
urogynecologic patients undergoing outpatient-urodynamics


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women, aged >= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a tertiary referral center for urogynecologic conditions

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01663181

Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Wolfgang Umek, Prof Medical University Vienna Austria
  More Information

Responsible Party: Wolfgang Umek, MD,, Medical University of Vienna Identifier: NCT01663181     History of Changes
Other Study ID Numbers: 413/2009
Study First Received: August 5, 2012
Last Updated: August 10, 2016

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Pelvic Organ Prolapse
Urinary Tract Infections
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Pathological Conditions, Anatomical
Infection processed this record on May 22, 2017