New prostate implant aims to ease bathroom troubles
NCT ID NCT06136819
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new device called RT-310, a small implant placed inside the prostate to treat bothersome urinary symptoms from an enlarged prostate. The trial includes 20 men aged 50 to 80 who have not gotten enough relief from medication. The main goal is to check if the implant is safe and feasible, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RT-310 implant
- What this could lead to
- If it works, this could offer a new, less invasive option to relieve frequent or urgent urination caused by an enlarged prostate.
- What could go wrong
- This is a very early, small safety study with only 20 men. It is not designed to prove the implant works, and side effects or lack of benefit are possible.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2024
- 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
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50 to 80 years
- Sex
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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 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.
Key Inclusion Criteria: * Male gender * Diagnosis of symptomatic BPH * Age ≥ 50 years up to 80 years * International Prostate Symptom Score (IPSS) ≥ 13 * Prostate volume 30 to 80 cc per ultrasound * Inadequate response and/or refusal of medical therapy for LUTS Key Exclusion Criteria: * Current urinary retention or at significant risk of urinary retention after drug washout * Have an obstructive or protruding median lobe of the prostate * Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate * Previous pelvic surgery or irradiation * History of neurogenic or atonic bladder * Stress urinary incontinence, mixed or urge incontinence * History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder * History of compromised renal function or upper urinary tract disease * Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required * Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) * No more than two documented active urinary tract infections (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catheterization specimen) * Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor * Presence of a penile implant or stent(s) in the urethra or prostate * PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy * Sensitivity to RT-310 * Unable to undergo magnetic resonance imaging (MRI) such as presence of cardiac pacemaker or implanted cardiac defibrillator * Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis
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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.
Contacts and locations
Locations
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Australian Clinical Trials
Wahroonga, New South Wales, 2076, Australia
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Goldfields Urology
Bendigo, Victoria, 3550, Australia
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Tauranga Urology Research
Tauranga, North Island, 3112, New Zealand
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Western Urology
Maribyrnong, Victoria, Australia
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?
- Can a fluid injection make prostate surgery safer and less bloody?