Health TrialsbyHealthPanel

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

ConditionErectile Dysfunction Following Radical Prostatectomy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Urine-Derived Exosomes (USC-Exos)

    Biological/Vaccine

    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

    Procedure/Surgery

    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

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Intracavernosal Urine-Derived Exosomes (USC-Exos)Experimental treatment 1 intervention
Group B: Rectal Medical Ozone TherapyExperimental treatment 1 intervention
Group C: Standard Penile RehabilitationActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Change in Peak Systolic Velocity (PSV)

Objective measurement of cavernous arterial competence following an intracavernosal injection of a vasoactive agent, assessed via Pharmacopenile Duplex Ultrasonography (PPDU). Reported in centimeters per second (cm/s).

Time frame
Baseline and 6 Months Post-Intervention.
2

Change in End-Diastolic Velocity (EDV)

Objective measurement of the cavernous veno-occlusive mechanism following an intracavernosal injection of a vasoactive agent, assessed via Pharmacopenile Duplex Ultrasonography (PPDU). Reported in centimeters per second (cm/s).

Time frame
Baseline and 6 Months Post-Intervention.
3

Change in Resistive Index (RI)

Calculated ratio based on the peak systolic and end-diastolic velocities, used to evaluate penile vascular resistance via Pharmacopenile Duplex Ultrasonography (PPDU). It is reported as a unitless ratio.

Time frame
Baseline and 6 Months Post-Intervention.

Other outcomes

Sponsors and contacts

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Medipol University

Lead sponsor

Istanbul Medipol University Hospital

Sponsor institution

Başakşehir Çam & Sakura City Hospital

Collaborator

Istanbul Medipol University Hospital

Collaborator

Source ClinicalTrials.gov

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