Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction

Erectile dysfunction (ED) remains a prevalent and distressing complication followingrobotic‐assisted radical prostatectomy (RARP), primarily manifesting secondary tocavernous nerve neuropraxia, subsequent localized hypoxia, and fibrotic remodeling of thecorpus cavernosum. While standard pharmacotherapies (e.g., PDE5 inhibitors) offersymptomatic relief, they fail to reverse the underlying endothelial and neuraldetriments.Recent preclinical and clinical data suggest that stem cell‐derived therapies,particularly cell‐free exosomes, exhibit significant proangiogenic and antifibroticproperties. Extracellular vesicles containing components of the stem cell secretome, suchas microRNAs, facilitate endothelial cell proliferation and tissue repair. Conversely,systemic ozone therapy has been hypothesized to enhance oxygen delivery, upregulateantioxidant enzymes, and modulate inflammatory cascades, potentially mitigatingpost‐surgical ischemia. In this trial, eligible post‐RARP patients will be randomized(1:1) to receive either a targeted intracavernosal injection of urine‐derived exosomes(USC‐Exos) or a scheduled regimen of rectal ozone‐oxygen mixture insufflation. Erectilecapacity, penile vascular hemodynamics (assessed via pharmacopenile duplexultrasonography), and general health status will be prospectively monitored at baseline,3, and 6 months post‐intervention.