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Could Urine-Derived exosomes or ozone therapy restore erections after prostate cancer surgery?

NCT ID NCT07707505

Disease control Sponsor: Medipol University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial tests two experimental treatments for erectile dysfunction in men who have had robotic prostate surgery for prostate cancer. One group receives an injection of urine-derived exosomes into the penis, while the other gets ozone gas delivered through the rectum. Researchers will measure improvements in erectile function over six months using a standard questionnaire and ultrasound.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
urine-derived exosomes (USC-Exos) and rectal medical ozone insufflation
What this could lead to
If successful, this could offer new, non-hormonal treatment options for erectile dysfunction after prostate surgery, potentially restoring function without standard medications.
What could go wrong
This is an early-stage trial with only 60 participants, so results may not apply to everyone. Both treatments are experimental and their long-term safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction following radical prostatectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Başakşehir Çam Sakura City Hospital

    Istanbul, Başakşehir, Turkey (Türkiye)

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