Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-75
SponsorMedipol University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Urine-Derived Exosomes (USC-Exos)
- Rectal Medical Ozone Insufflation
- Daily Phosphodiesterase type 5 (PDE5) Inhibitor
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Medipol University
Lead sponsor
Istanbul Medipol University Hospital
Sponsor institution
Başakşehir Çam & Sakura City Hospital
Collaborator
Istanbul Medipol University Hospital
Collaborator
Source ClinicalTrials.gov