MedTrace Logo

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

NCT07707505 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-16

No results posted yet for this 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.

Conditions

  • Erectile Dysfunction Following Radical Prostatectomy

Interventions

BIOLOGICAL

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.

PROCEDURE

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.

DRUG

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.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    collaborator OTHER_GOV

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-01-01
Completion
2027-04-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707505 on ClinicalTrials.gov