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Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663181
First Posted: August 13, 2012
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wolfgang Umek, MD, Medical University of Vienna
  Purpose

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.


Condition
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 Wolfgang Umek, MD, 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)
Groups/Cohorts
urogynecologic patients undergoing outpatient cystoscopy
urogynecologic patients undergoing outpatient-urodynamics

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663181


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

Responsible Party: Wolfgang Umek, MD, ao.Univ.Prof.Dr.univ.med, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01663181     History of Changes
Other Study ID Numbers: 413/2009
First Submitted: August 5, 2012
First Posted: August 13, 2012
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Prolapse
Urinary Tract Infections
Pelvic Organ Prolapse
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