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Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction
Sponsor: Medipol University
Summary
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.
Official title: Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy
Key Details
Gender
MALE
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-01
Completion Date
2027-04-01
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
Urine-Derived Exosomes (USC-Exos)
A single (or protocol-specified sequenced) bilateral intracavernosal injection of a sterile, cell-free urine-derived exosome suspension (e.g., 2 cc) into the corpus cavernosum, performed under clinical setting conditions.
Rectal Medical Ozone Insufflation
Administration of a standardized medical ozone and oxygen gas mixture (e.g., 30-40 µg/mL concentration) via rectal insufflation. The treatment will be administered for a predetermined number of sessions (e.g., 10 sessions spanning over 5 weeks) using a certified medical ozone generator.
Daily Phosphodiesterase type 5 (PDE5) Inhibitor
Oral administration of a daily low-dose PDE5 inhibitor (e.g., Tadalafil 5 mg once daily) for a continuous duration of 6 months, aligning with standard clinical guidelines for post-operative erectile dysfunction management.
Locations (1)
Başakşehir Çam Sakura City Hospital
Istanbul, Başakşehir, Turkey (Türkiye)