Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction (NCT07707505) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction
Turkey (Türkiye)60 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
45 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in International Index of Erectile Function (IIEF-5) Score
Timeframe: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.