Ralph, David

Abstract Introduction A new three-piece inflatable penile prosthesis was introduced in 2019. The Rigicon Infla10® has been implanted in 26 centers by 103 physicians. Clinical investigation for FDA approval in United States will begin in late 2022. Objective We report initial survival from explantation and revision rates for infection, mechanical failure and medical problems. Data was obtained from analysis of Patient Information Forms (PIFs) submitted to the manufacturer. Patient information data was omitted prior to analysis. Methods 319 patients implanted from 1/06/2019 to 12/31/2021 were followed to analyze device durability from revision/removal and rates of reoperation for infection, mechanical failure or medical reason. Results Mean follow-up was 21.2 months with a range of 5-36 months. Mean age was 58.5. 4.38% required removal/revision. Mechanical failure was 2.5%. There were no infections reported and only two (0.6%) medical problems (component out of place). One Peyronie's patient required revision for inadequate straightening (0.03% Three patients (0.9%) requested device removal for dissatisfaction. A total of 95.6% of Rigicon Infla10® was free from explant or revision 13 months from the original implant date. Kaplan Meier analysis revealed cumulative survival of the device at 12, 24 and 36 months was 95.6%, 94.7% and 95.7% until surgical invention. Conclusions While this is a retrospective study derived from volunteered Patient Information Forms, we believe the vast majority of the early Rigicon Infla10® performed prior to 1/2022 were included in the analysis. Early results show initial durability from re-operation equivalent to contemporary, devices. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Rigicon, Boston Scientific, Coloplast.

ABSTRACT Introduction Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. Aim To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. Methods A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. Main Outcome Measures This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. Results In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. Conclusion A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies.