Local anaesthesia eluting property of Coloplast Titan penile prosthesis hydrophilic coating: An in-vitro drug elution profile and a randomised double-blind clinical outcome study
1: AndroUrology Centre, Australia
Local anaesthesia eluting property of Coloplast Titan penile prosthesis hydrophilic coating: An in-vitro drug elution profile and a randomised double-blind clinical outcome study.
Objectives: A two-part study to provide proof-of-concept with in-vitro analysis of drug elution property, and to evaluate the clinical outcome with Titan penile prosthesis hydrophilic coating dipped in local anaesthesia agent.
Material and Method: An in-vitro analysis of local anaesthesia eluting property of hydrophilic coating to determine the amount and duration of local anaesthesia elution, and examine if the addition of local anaesthesia agent will dilute anti-microbial property of hydrophilic coating. Following internal ethics approval, a pilot study was conducted with 40 men randomised to receive Titan’s penile prosthesis dipped with or without 0.75% Ropivacaine and 0.5% Marcaine. An independent third-party survey with objective measurement of pain score (visual analog scale, VAS), analgesia requirement (opioid dose equivalence) and time to penile prosthesis recycling.
Result: In vitro-release kinetics confirmed passive drug elution above the minimum inhibitory concentration. The minimum local anaesthetic concentration (MLAC) of 0.75% Ropivacaine and 0.5% Marcaine was sustained over the 14 days of in-vitro drug elution test. The hydrophilic coating with combination local anesthesia and antimicrobial drugs showed sustained elution and zone of microbial inhibition at day 1, 3, 7 and 14 (p<0.05). In the clinical study, patients with Titan penile prosthesis dipped in local anaesthesia reported lower VAS score (p<0.05), less analgesia requirement (p<0.05) and shorter time to penile prosthesis recycling (p=0.08).
Conclusions: Coloplast Titan hydrophilic coating provides a promising avenue to provide adjunctive analgesia in penile prosthesis implant patient care based on in-vitro drug elution profile, with clinical outcomes showing lower pain score and analgesia requirement, and shorter time to prosthesis recycling, without compromising the antibacterial property, when the Titan penile prosthesis is dipped in local anaesthesia agent and antimicrobial drugs.
Work supported by industry: yes, by Coloplast (industry funding only - investigator initiated and executed study).Go Back