Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wolfgang Umek, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01663181
First received: August 5, 2012
Last updated: August 8, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wolfgang Umek, ao.Univ.Prof.Dr.univ.med, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01663181     History of Changes
Other Study ID Numbers: 413/2009
Study First Received: August 5, 2012
Last Updated: August 8, 2012
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Tract Infections
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Infection
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014