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 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.
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).
In this prospective study, Instillagel(®) Lido was not inferior to Xylocaine(®) gel for local analgesia during flexible cystoscopy in male patients.
Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie. 2016 [Epub ahead of print]
B Peyronnet, S-J Drouin, F-D Gomez, T Seisen, A Goujon, B Pradere, M-O Bitker, V Phé, M Rouprêt
Service d'urologie, CHU de Rennes, 35000 Rennes, France., Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France., Service d'urologie, CHU de Liège, 4000 Liège, Belgique., Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France. Electronic address: .