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.

NCT Number	NCT07707505
Lead Sponsor	Medipol University Collaborators: Başakşehir Çam & Sakura City Hospital, Istanbul Medipol University Hospital
Conditions	Erectile Dysfunction Following Radical Prostatectomy
Enrollment	60 participants
Start Date	2026-08-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-16