Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

NCT ID: NCT01663181

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

urogynecologic patients undergoing outpatient cystoscopy

No interventions assigned to this group

urogynecologic patients undergoing outpatient-urodynamics

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Umek, MD

ao.Univ.Prof.Dr.univ.med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Umek, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna Austria

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

413/2009

Identifier Type: -

Identifier Source: org_study_id