Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

NCT01663181 | Completed

• 1 other identifier: 413/2009
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence; Overactive Bladder; Pelvic Organ Prolapse; Recurrent Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• subjective pain perception immediately after examination as measured by a standard visual analog scale

  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

  immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)

Secondary Outcomes (1)

• difference between anticipated pain and actual pain perception

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

Study Arms (2)

urogynecologic patients undergoing outpatient cystoscopy

urogynecologic patients undergoing outpatient-urodynamics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.

You may not qualify if:

• age ≤ 18 years
• insufficient ability to understand German
• pregnancy
• participation in another clinical study at the same time

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive; Pelvic Organ Prolapse; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Prolapse; Pathological Conditions, Anatomical; Infections

Study Officials

• Wolfgang Umek, Prof

  Medical University Vienna Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ao.Univ.Prof.Dr.univ.med

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 13, 2012
• Study Start: May 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

AU (1)