(233) FIRST SINGLE SURGEON SAFETY AND PATIENT SATISFACTION STUDY FOR THE NEW RIGICON INFLA10® INFLATABLE PENILE PROSTHESIS

Abstract Introduction Rigicon is a newer inflatable penile prostheses (IPP) manufacturer that has produced the Infla10® IPP for countries outside the United States (US) since 2019. Federal Drug Administration (FDA) studies for approval of Infla10® in the US are presently underway. This study aims to report the first efficacy and safety study of the newly available Rigicon Infla10® inflatable penile prosthesis (IPP). Objective This study aims to report the first efficacy and safety study of the newly available Rigicon Infla10® inflatable penile prosthesis (IPP). Methods A single surgeon’s first 58 patients who underwent Rigicon Infla10® IPP implantation between 2019 and 2023 were included. Most patients (70%) received the Infla10 X (girth expansion) cylinder, and 30% received the Infla10 AX (length and girth expansion) model. Follow-up ranged from 4 to 42 months (median 19 months). Results Reoperation was required in 5 patients (8.6%). Complication rates were 1.7% urethral erosion (n = 1), 1.7% infection requiring explant (n = 1), and 5% mechanical malfunction due to tubing breakage at pump junction (n = 3). The tubing issue was addressed by the manufacturer, resulting in no additional mechanical concerns. Kaplan–Meier analysis demonstrated rates of cumulative survival of the device at 12 and 24 months were 96.6% and 93.8%, respectively. Overall, 53 patients (91.4%) were satisfied and would recommend the procedure. Diminished satisfaction was due to perceived penile shortening in 3 patients (5.1%), and difficulty learning pump cycling in 2 patients (3.4%). Conclusions This single surgeon series demonstrates high rates of patient satisfaction with appropriate early safety from revision. While very new in the marketplace, the Infla10® IPP shows early comparable efficacy and safety from revision compared to competitive 3-piece devices previously available for decades. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Rigicon, Uramix, Coloplast, International Medical Devices.