Overactive Bladder, Pelvic Organ Prolapse, Recurrent Urinary Tract Infections, Urinary Incontinence
Conditions
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.
Interventions
None listed
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| subjective pain perception immediately after examination as measured by a standard visual analog scale | 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
| Measure | Time frame |
|---|---|
| difference between anticipated pain and actual pain perception | immediately before and immediately after the examination (zero to ten minutes after undergoing examination) |
Countries
Austria
Outcome results
None listed