title: [Local analgesia during flexible cystoscopy in male patients: A non-inferiority study comparing Xylocaine®gel to Instillagel®Lido].
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  In this prospective study, Instillagel®Lido was not inferior to Xylocaine®gel for local analgesia during flexible cystoscopy in male patients.
  
  
  METHODS
  4.
authors.affiliation: Service d'urologie, CHU de Rennes, 35000 Rennes, France.
authors.forename: B
authors.initials: B
authors.lastname: Peyronnet
authors.affiliation: Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France.
authors.forename: S-J
authors.initials: SJ
authors.lastname: Drouin
authors.affiliation: Service d'urologie, CHU de Liège, 4000 Liège, Belgique.
authors.forename: F-D
authors.initials: FD
authors.lastname: Gomez
authors.affiliation: Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France.
authors.forename: T
authors.initials: T
authors.lastname: Seisen
authors.affiliation: Service d'urologie, CHU de Rennes, 35000 Rennes, France.
authors.forename: A
authors.initials: A
authors.lastname: Goujon
authors.affiliation: Service d'urologie, CHU de Rennes, 35000 Rennes, France.
authors.forename: B
authors.initials: B
authors.lastname: Pradere
authors.affiliation: Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France.
authors.forename: M-O
authors.initials: MO
authors.lastname: Bitker
authors.affiliation: Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France.
authors.forename: V
authors.initials: V
authors.lastname: Phé
authors.affiliation: Service d'urologie, hôpital Pitié-Salpétrière, AP-HP, 47-83, boulevard de l'Hopital, 75013 Paris, France. Electronic address: mroupret@gmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Rouprêt
mesh_terms: D000368:Aged; D000698:Analgesia / Q000379:methods*; D000779:Anesthetics, Local / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000627:therapeutic use*; D003558:Cystoscopy; D004338:Drug Combinations; D005782:Gels; D006801:Humans; D007430:Intraoperative Care; D008012:Lidocaine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D011446:Prospective Studies
chemical_list: D000779:Anesthetics, Local; D004338:Drug Combinations; D005782:Gels; C008129:chlorhexidine gluconate, lidocaine drug combination; D008012:Lidocaine; D002710:Chlorhexidine
keywords: Anesthesia; Anesthésie; Cystoscopie; Cystoscopy; Gel; Homme; Male; Urethra; Urètre