(813) Real-World Complications of Intracavernosal Therapy for Erectile Dysfunction: A 1,794-Patient Cohort

Introduction Intracavernosal therapy is an effective treatment for erectile dysfunction (ED), especially in patients who do not respond to phosphodiesterase type 5 inhibitors. However, its use may lead to adverse events such as pain, fibrosis, and priapism, with variable incidence reported in the literature. Quadmix and Trimix have shown high satisfaction rates but with a higher risk of adverse events compared to alprostadil as monotherapy. Despite their widespread use, real-world evidence remains limited. This study describes complications associated with intracavernosal therapy in a large clinical cohort over four years. Objective To estimate the proportion of complications related to intracavernosal medication for ED in a cohort of men treated in Mexico. Methods A descriptive observational study was conducted among men with ED treated with intracavernosal medication between 2020 and 2023 in multiple clinics within a single healthcare network in Mexico. Clinical and sexual health data were reviewed. We estimated the proportion of complications, including priapism, pain, urethral bleeding, hematoma, fibrosis, and penile curvature. Each event was characterized regarding management approach and clinical outcomes. Results During the study period, 1,794 men received intracavernosal therapy. A total of 226 complication reports corresponding to 152 patients were identified. Quadmix was the most commonly used medication (91.6%), followed by alprostadil (5.3%) and Trimix (3.1%). Dosage ranged from 6–80 U for alprostadil, 4–110 U for Quadmix, and 8–100 U for Trimix. The most frequent complication was pain (8.1%; n=147), followed by priapism (4.7%; n=85). Other reported complications were hematoma (0.83%), fibrosis (0.83%), urethral bleeding (0.55%), and penile curvature (0.22%). Among priapism cases, the median duration was 5 hours (IQR = 1). Two episodes resolved spontaneously; 44 were managed with physical measures (compression, exercise, cold application); 20 required etilefrine (maximum reported dose 160 units); and 10 required adrenaline. Cavernosal fibrosis occurred as a sequela in one patient. Regarding pain according to the Visual Analog Scale (VAS), 5.4% reported grade 1, 13.6% grade 2, 32.7% grade 3, 26.5% grade 4, and 21.8% grade 5. Conclusions In this cohort, the overall complication rate associated with intracavernosal therapy was 12.6%, with pain and priapism being the most frequent events, consistent with international data. Most priapism episodes resolved with conservative or pharmacologic management, with cavernosal fibrosis identified in only one case. Although Quadmix was the most commonly used formulation, its safety profile aligned with previous reports. These findings support intracavernosal therapy as an effective and generally safe option for ED, highlighting the importance of patient education and structured follow-up for early identification and management of complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Medical Group