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

Официальное название

Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy

Обзор

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.

Подробное описание

Erectile dysfunction (ED) remains a prevalent and distressing complication following robotic-assisted radical prostatectomy (RARP), primarily manifesting secondary to cavernous nerve neuropraxia, subsequent localized hypoxia, and fibrotic remodeling of the corpus cavernosum. While standard pharmacotherapies (e.g., PDE5 inhibitors) offer symptomatic relief, they fail to reverse the underlying endothelial and neural detriments.Recent preclinical and clinical data suggest that stem cell-derived therapies, particularly cell-free exosomes, exhibit significant proangiogenic and antifibrotic properties. Extracellular vesicles containing components of the stem cell secretome, such as microRNAs, facilitate endothelial cell proliferation and tissue repair. Conversely, systemic ozone therapy has been hypothesized to enhance oxygen delivery, upregulate antioxidant enzymes, and modulate inflammatory cascades, potentially mitigating post-surgical ischemia. In this trial, eligible post-RARP patients will be randomized (1:1) to receive either a targeted intracavernosal injection of urine-derived exosomes (USC-Exos) or a scheduled regimen of rectal ozone-oxygen mixture insufflation. Erectile capacity, penile vascular hemodynamics (assessed via pharmacopenile duplex ultrasonography), and general health status will be prospectively monitored at baseline, 3, and 6 months post-intervention.

Вмешательства

• Биопрепарат 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.
• Процедура 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.
• Препарат 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.

Первичные конечные точки

• Mean Change in International Index of Erectile Function (IIEF-5) Score [Срок оценки: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.]

Вторичные конечные точки (3)

• Change in Peak Systolic Velocity (PSV) [Срок оценки: Baseline and 6 Months Post-Intervention.]
• Change in End-Diastolic Velocity (EDV) [Срок оценки: Baseline and 6 Months Post-Intervention.]
• Change in Resistive Index (RI) [Срок оценки: Baseline and 6 Months Post-Intervention.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07707505 · 1453145315453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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