Local analgesia during flexible cystoscopy in male patients: A non-inferiority study comparing Xylocaine® gel to Instillagel® Lido

Introduction. - Local anesthesia using urethral gel has been proven to reduce discomfort of male patients during flexible cystoscopy. This study was a non-inferiority study between two lidocain-containing urethral gel (Instillagel (R) Lido and Xylocaine (R) gel). Methods. - A prospective single center study was conducted between June 2014 and November 2014. Male patients seen in the office and in whom a flexible cystoscopy was planned were included in the present study and received urethral instillation of either Xylocaine (R) gel or Instillagel (R) Lido at least 5 minutes before flexible cystoscopy. No other anesthetic agent was used. Primary endpoint was pain during the procedure, assessed through visual analog scale (VAS) from 0 to 10. Results. - Four hundred and sixty-one men were included: 233 in the Instillagel (R) Lido group and 228 in the Xylocaine (R) gel group. Indications of flexible cystoscopy non-muscle invasive bladder cancer follow-up in 44 % of cases, hematuria work-up in 21 % of cases and lower urinary tract symptoms work-up in 35 %. Patients' age was comparable betwwen both groups: 64.5 years (+/- 1.1) in the Instillagel (R) Lido group and 66.2 years (+/- 1.1) in the Xylocaine (R) gel group (P=0.29). The mean VAS was 0.8 (+/- 0.1) in the Instillagel (R) Lido group and 0.6 (+/- 0.1) in the Xylocaine (R) gel group (P=0.10). The non-inferiority criterion was reached (P<0.001) as the average difference in VAS between the two groups was 0.2 with a confidence interval not comprising 1 (Cl 97.5 %: -0.47; 0.07). Conclusion. - In this prospective study, Instillagel (R) Lido was not inferior to Xylocaine (R) gel for local analgesia during flexible cystoscopy in male patients. (C) 2016 Elsevier Masson SAS. All rights reserved.