drugset / Trial / NCT07707505
Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction
Not yet recruiting
60 enrolled
Medipol University
Başakşehir Çam & Sakura City Hospital · collabIstanbul Medipol University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2027-01-01
- Completion
- 2027-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 5 mg | Oral |
| Subject | Urine-Derived Exosomes | Other / unclassified | 2 ml | Intravenous |
Indications
No indication recorded.