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New prostate injection aims to help men pee better

NCT ID NCT07381127

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a liquid called INTUPRO that is injected into the prostate to shrink tissue and improve urine flow in men with enlarged prostate (BPH). 31 men aged 45+ with moderate to severe symptoms will receive the treatment and be followed for 3 months. The goal is to see if it reduces nighttime bathroom trips, hesitancy, and urgency, and helps remove the urinary catheter.

What this could mean

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

Active substance
INTUPRO ionic fluid (a liquid injected into the prostate to shrink tissue)
What this could lead to
If it works, this could offer a new, minimally invasive option to relieve BPH symptoms without surgery.
What could go wrong
This is a very small, early study with no control group, so results may not be reliable. Risks include infection, bleeding, and urinary retention.

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 31 people

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

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

45 years and older

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: * • Male patient aged 45 years or older * Prostate volume greater than 30 grams * An International Prostate Symptom Score (IPSS) of 12 or higher * Presence of obstructive urinary symptoms, such as difficulty starting urination, leakage of urine after voiding, or a feeling of incomplete bladder emptying. This criterion may include patients who have previously been diagnosed with prostate cancer and completed treatment, but are experiencing urinary problems. * Life expectancy of at least 3 months * Ability to understand the study information and provide written informed consent * Willingness and ability to comply with all study requirements, including procedures, clinical assessments, and follow-up visits Exclusion Criteria: * Urethral stricture * Bladder stones * Prostate volume 120 grams or greater * Presence of a prostate median lobe * History of bladder cancer or kidney cancer, and/or prior surgery related to these conditions * Previous radiation therapy to the pelvic region * Prior invasive surgical treatment for BPH symptoms * The Principal Investigator believes the patient would not tolerate the procedure * Presence of a cognitive impairment that, in the opinion of the Principal Investigator, would interfere with the patient's ability to provide reliable data or to safely complete the study * Bleeding disorders * Known allergy or intolerance to MRI contrast agents required for imaging used to evaluate treatment effectiveness after ionic fluid application * Other significant concurrent medical conditions that, in the investigator's judgment, could prevent clinical benefit from the procedure or could place the patient or study objectives at risk (including, but not limited to, active infection, kidney dysfunction, or significant comorbidities) * Significant medical or psychiatric illness * Participation in another clinical study involving a device, drug, or procedure that has not been completed or that could affect the outcomes of this study * Inability or unwillingness to undergo MRI examinations during the study period for any reason

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Koç University Hospital Research Center

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

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