Erectile Dysfunction Following Radical ProstatectomyREHAB-RARPNCT07707505
Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction
A study testing Urine-Derived Exosomes (USC-Exos), Rectal Medical Ozone Insufflation and Daily Phosphodiesterase type 5 (PDE5) Inhibitor in people with Erectile Dysfunction Following Radical Prostatectomy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Urine-Derived Exosomes (USC-Exos), Rectal Medical Ozone Insufflation and Daily Phosphodiesterase type 5 (PDE5) Inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam Sakura City Hospital
Istanbul, Başakşehir
Ali ihsan Memmi, 905379220997, alimemmi@gmail.com
Ali ihsan Memmi, MD
About this study
Official title: Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy
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.
Read the detailed description
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.
- Being tested
- Urine-Derived Exosomes (USC-Exos), Rectal Medical Ozone Insufflation, Daily Phosphodiesterase type 5 (PDE5) Inhibitor
- Keywords
- Exosomes, Rectal Ozone Insufflation, Robotic-Assisted Radical Prostatectomy, Penile Rehabilitation, Extracellular Vesicles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Rectal Medical Ozone InsufflationProcedure or 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) InhibitorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Daily Phosphodiesterase type 5 (PDE5) Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.
Secondary outcomes (3)
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).
Measured: Baseline and 6 Months Post-Intervention.
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).
Measured: Baseline and 6 Months Post-Intervention.
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.
Measured: Baseline and 6 Months Post-Intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Istanbul Medipol University Hospital
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707505
- Sponsor's protocol ID
- 1453145315453
- Acronym
- REHAB-RARP
- Status last verified
- Jul 2026
- First submitted
- 17 May 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07707505
- Acronym / sponsor ID
- REHAB-RARP / 1453145315453
- Keywords
- Exosomes, Rectal Ozone Insufflation, Robotic-Assisted Radical Prostatectomy, Penile Rehabilitation, Extracellular Vesicles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Istanbul Medipol University Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracavernosal Urine-Derived Exosomes (USC-Exos) | Experimental | Biological: Urine-Derived Exosomes (USC-Exos)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. |
| Rectal Medical Ozone Therapy | Experimental | Procedure: Rectal Medical Ozone InsufflationParticipants 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. |
| Standard Penile Rehabilitation | Active comparator | Drug: Daily Phosphodiesterase type 5 (PDE5) InhibitorParticipants 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Intracavernosal Urine-Derived Exosomes (USC-Exos) |
| Rectal Medical Ozone InsufflationAdministration 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. | Procedure or surgery | Rectal Medical Ozone Therapy |
| Daily Phosphodiesterase type 5 (PDE5) InhibitorOral 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. | Drug | Standard Penile Rehabilitation |
Primary outcome
Mean Change in International Index of Erectile Function (IIEF-5) Score
Time frame: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.
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.
3 secondary outcomes
Change in Peak Systolic Velocity (PSV)
Time frame: Baseline and 6 Months Post-Intervention.
Change in End-Diastolic Velocity (EDV)
Time frame: Baseline and 6 Months Post-Intervention.
Change in Resistive Index (RI)
Time frame: Baseline and 6 Months Post-Intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine-Derived Exosomes (USC-Exos), Rectal Medical Ozone Insufflation and Daily Phosphodiesterase type 5 (PDE5) Inhibitor in people with Erectile Dysfunction Following Radical Prostatectomy, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali ihsan Memmi (90 537 999 0941, alimemmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in International Index of Erectile Function (IIEF-5) Score (time frame: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.