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Clinical Trials in Turkey / NCT07707505
Starting soon Not applicable

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

NCT07707505 · tracked via the Priya Life Science Turkey tracker
Sponsor
Medipol University
Phase
Not applicable
Started
2026-08-01
Last updated
2026-07-16

Condition(s) studied

Erectile Dysfunction Following Radical Prostatectomy

Investigational drug(s) / intervention(s)

Urine-Derived Exosomes (USC-Exos)Rectal Medical Ozone InsufflationDaily Phosphodiesterase type 5 (PDE5) Inhibitor

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.

Study 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.

Eligibility

Sex
MALE
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean Change in International Index of Erectile Function (IIEF-5) Score — Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.
    The International Index of Erectile Function (IIEF-5) is a validated self-reporting psychometric instrument utilized to assess erectile function severity. The total score ranges from a minimum of 5 to a maximum of 25. Higher scores represent better erectile function (a better outcome), with scores ≤21 indicating varying degrees of erectile dysfunction and 22-25 representing normal erectile function.

Trial sites (1)

FacilityCityRegionStatus
Başakşehir Çam Sakura City Hospital Istanbul Başakşehir

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07707505 on ClinicalTrials.gov ↗ ← All trials in Turkey