Anesthésie locale pour fibroscopie chez l’homme : étude de non-infériorité comparant le Xylocaine® gel à l’Instillagel® Lido

Abstract

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® Lido and Xylocaine® gel). A prospective single center study was conducted between June2014and November2014. 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® gel or Instillagel® Lido at least 5minutes before flexible cystoscopy. No other anesthetic agent was used. Primary endpoint was pain during the procedure, assessed through visual analog scale (VAS) from 0to 10. Four hundred and sixty-one men were included: 233in the Instillagel® Lido group and 228in the Xylocaine® 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: 64.5years (±1.1) in the Instillagel® Lido group and 66.2years (±1.1) in the Xylocaine® gel group (P=0.29). The mean VAS was 0.8 (±0.1) in the Instillagel® Lido group and 0.6 (±0.1) in the Xylocaine® 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 0.2with a confidence interval not comprising 1 (CI97.5%: -0.47; 0.07). In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients. 4.