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

NCT07707505 | Not Yet Recruiting DMC

• 1 other identifier: 1453145315453
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exosomes; Rectal Ozone Insufflation; Robotic-Assisted Radical Prostatectomy; Penile Rehabilitation; Extracellular Vesicles

Outcome Measures

Primary Outcomes (1)

• Mean Change in International Index of Erectile Function (IIEF-5) Score

  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.

  Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.

Secondary Outcomes (3)

• Change in Peak Systolic Velocity (PSV)

  Baseline and 6 Months Post-Intervention.

• Change in End-Diastolic Velocity (EDV)

  Baseline and 6 Months Post-Intervention.

• Change in Resistive Index (RI)

  Baseline and 6 Months Post-Intervention.

Study Arms (3)

Intracavernosal Urine-Derived Exosomes (USC-Exos)

EXPERIMENTAL

Participants randomized to this arm will receive targeted intracavernosal injections of cell-free, urine-derived exosomes. The intervention aims to evaluate the proangiogenic and regenerative effects of the exosome secretome on the cavernous tissue following radical prostatectomy.

Biological: Urine-Derived Exosomes (USC-Exos)

Rectal Medical Ozone Therapy

EXPERIMENTAL

Participants randomized to this arm will receive protocolized systemic rectal medical ozone insufflation. This arm evaluates the systemic antioxidant, anti-inflammatory, and tissue oxygenation benefits of ozone therapy on post-operative erectile functional recovery.

Procedure: Rectal Medical Ozone Insufflation

Standard Penile Rehabilitation

ACTIVE COMPARATOR

Participants randomized to this arm will receive the current standard of care for post-prostatectomy penile rehabilitation. This serves as the active control group to benchmark the efficacy of the experimental regenerative therapies.

Drug: Daily Phosphodiesterase type 5 (PDE5) Inhibitor

Interventions

Urine-Derived Exosomes (USC-Exos) BIOLOGICAL

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.

Intracavernosal Urine-Derived Exosomes (USC-Exos)

Rectal Medical Ozone Insufflation PROCEDURE

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.

Rectal Medical Ozone Therapy

Daily Phosphodiesterase type 5 (PDE5) Inhibitor DRUG

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.

Standard Penile Rehabilitation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: post prostatecmy erectile dysfunction is only male gender issue.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead
• Istanbul Medipol University Hospital: collaborator
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Başakşehir Çam Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

PDE5A protein, human

Central Study Contacts

Ali ihsan Memmi

CONTACT

90 537 999 0941; alimemmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)