New prostate injection aims to help men pee better
NCT ID NCT07381127
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
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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
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Koç University Hospital Research Center
RECRUITINGIstanbul, 34010, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a gel stop bleeding after prostate surgery and send men home the same day?
- Can a smarter needle angle make prostate relief safer and easier?
- Can a Needle-Free prostate treatment match implant surgery?
- Can sound waves offer a lasting fix for prostate problems?
- Robotic precision could transform prostate surgery