Interim Results of Rigicon Penile Prosthesis Implantation in a Single Center: The Largest Series in Türkiye.

Abstract

Objective: To analyze data from patient information forms (PIFs) submitted to the manufacturer of a new 3-piece inflatable penile prosthesis (IPP), the Rigicon Infla10® , to summarize interim outcomes of 250 implantations in a single center, which is the largest series in Türkiye.

Methods: A retrospective review of PIFs from 250 patients implanted with the IPP between January 2021 and December 2023 was performed to assess patient characteristics, surgical data, device durability, patient satisfaction, and rates of reoperation for any reason.

Results: The mean ± SD (range) follow-up was 21.2 ± 8.7 (6-36) months and the mean ± SD patient age was 56.2 ± 9.1 years. The average surgical time was 47 minutes. Of the total, 2.4% of devices required removal or revision. Mechanical failure of the device was reported in 3 patients (1.2%). One patient (0.4%) required revision for noise during pumping. Two patients (0.8%) requested device removal because of dissatisfaction. No infections were observed in this series. A total of 97.6% of the Rigicon Infla10® devices were free from explant or revision. The satisfaction rate based on a single question asked to the patient by the surgeon 6 months after surgery was 98.4%.

Conclusion: All Rigicon Infla10® IPPs implanted in the center prior to January 2024 were included in the retrospective analysis of volunteered PIFs. Initial durability from reoperation was demonstrated to be superior compared to other contemporary devices. Additionally, high satisfaction with treatment outcomes was reported by 92.4% of patients.