Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Vienna, Østrig, 1090
- Medical University Vienna
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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urogynecologic patients undergoing outpatient cystoscopy
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urogynecologic patients undergoing outpatient-urodynamics
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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subjective pain perception immediately after examination as measured by a standard visual analog scale
Tidsramme: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
|
patients are assessed at three points in time:
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immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
difference between anticipated pain and actual pain perception
Tidsramme: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
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immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wolfgang Umek, Prof, Medical University Vienna Austria
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 413/2009
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