Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie · 2016
[Local analgesia during flexible cystoscopy in male patients: A non-inferiority study comparing Xylocaine® gel to Instillagel® Lido].
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Peyronnet B, Drouin S-J, Gomez F-D, Seisen T, Goujon A, Pradere B, Bitker M-O, Phé V, Rouprêt M
Аннотация
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® Lido and Xylocaine® 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® 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 0 to 10.
RESULTS: Four hundred and sixty-one men were included: 233 in the Instillagel® Lido group and 228 in 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: 64.5 years (±1.1) in the Instillagel® Lido group and 66.2 years (±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 0.2 with a confidence interval not comprising 1 (CI 97.5 %: -0.47; 0.07).
CONCLUSION: In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients.
LEVEL OF EVIDENCE: 4.
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® 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 0 to 10.
RESULTS: Four hundred and sixty-one men were included: 233 in the Instillagel® Lido group and 228 in 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: 64.5 years (±1.1) in the Instillagel® Lido group and 66.2 years (±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 0.2 with a confidence interval not comprising 1 (CI 97.5 %: -0.47; 0.07).
CONCLUSION: In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients.
LEVEL OF EVIDENCE: 4.