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

This prospective, randomized, controlled trial aims to evaluate and compare the therapeutic efficacy of intracavernosal urine-derived exosomes and systemic rectal ozone therapy in patients experiencing erectile dysfunction (ED) post-robotic-assisted radical prostatectomy (RARP). Patients will be randomized into two distinct intervention arms. The primary objective is to assess the functional recovery of the erectile tissue via the International Index of Erectile Function (IIEF-5) over a 6-month follow-up period. Secondary endpoints include penile hemodynamic alterations and overall health-related quality of life.

Inclusion Criteria: * History of Robotic-Assisted Radical Prostatectomy (ns-RARP) for localized prostate cancer. * Normal preoperative erectile function (retrospective IIEF-5 score \> 21). * Presence of a stable, sexually active heterosexual relationship. * Inadequate response or intolerance to maximum dose, on-demand oral Phosphodiesterase type 5 inhibitors (PDE5i). Exclusion Criteria: * History of adjuvant or salvage pelvic radiotherapy / androgen deprivation therapy (ADT). * Presence of severe anatomical penile deformities (e.g., active phase Peyronie's disease). * Uncontrolled endocrinological (e.g., HbA1c \> 8.5%) or cardiovascular comorbidities. * History of major cardiovascular events (myocardial infarction, stroke) within the preceding 6 months. * Current use of systemic anticoagulants (excluding low-dose prophylactic aspirin). * Concomitant use of any intraurethral alprostadil, vacuum erection devices (VED), or testosterone replacement therapy during the study period.