drugset / Trial / NCT03210038
Cystoscopy in Females: Is There a Difference Between Rigid and Flex Cystoscopy, and Does it Require Local Anasthesia?
RandomizedParallel-groupOpen-labelDiagnostic
Summary
Women arriving to the Urology department outpatient clinic at Assaf-Harofeh Medical Center in order to undergo a cystoscopy examination will be recruited. Patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus. Pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
Publications
- Results Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
- Results Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
- Results Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hubner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007.
- Results Stav K, Ohlgisser R, Siegel YI, Beberashvili I, Padoa A, Zisman A. Pain during Female Urethral Catheterization: Intraurethral Lubricant Injection versus Catheter Tip Lubrication--A Prospective Randomized Trial. J Urol. 2015 Oct;194(4):1018-21. doi: 10.1016/j.juro.2015.03.097. Epub 2015 Mar 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | — | Topical |