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Could a simple implant spare men from urinary pain after prostate radiation?

NCT ID NCT05148156

Symptom relief Sponsor: Northwell Health 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
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether placing a Urolift device in the prostate before stereotactic body radiation therapy (SBRT) can reduce urinary side effects like frequent urination, pain, and nighttime trips to the bathroom. About 20 men with both prostate cancer and benign prostatic hyperplasia (BPH) will receive the Urolift and then SBRT. Researchers will track symptom scores and quality of life for one year to see if the device helps.

What this could mean

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

Active substance
Urolift device
What this could lead to
If it works, this could offer a way to reduce urinary problems after prostate radiation, improving quality of life for men with BPH.
What could go wrong
This is a very small, early study (20 people) that is currently suspended. It may not show a clear benefit, and results may not apply to all patients.

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 20 people

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

Started

Dec 2021

Expected to finish

Mar 2028

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

50 to 99 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subject is 50 - 99 years of age * Subject has provided informed consent * Subject has diagnosis of prostate cancer requiring SBRT * Subject is able to complete self-administered questionnaires * Subject is a surgical candidate for Urolift * Subject has a diagnosis of BPH * Medical record documentation of prostate volume from 30-80 ml by TRUS * Absence of a middle lobe Exclusion Criteria: * Life expectancy \< 2 years * Currently enrolled in or plans to enroll in any concurrent drug or device study * Concurrent androgen deprivation therapy * Has an active infection (e.g., urinary tract infection or prostatitis) * Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis) * Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days * Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years * Diagnosis of lichen sclerosis * Neurogenic bladder or other neurologic disorder that affects bladder function * Diagnosis of polyneuropathy (e.g., diabetic) * History of lower urinary tract surgery * Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use * Subject has been catheterized or has a PVR \> 400 ml in the 14 days prior to the surgical procedure * Current diagnosis of bladder stones

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Dysuria Nocturia prostate cancer

As listed by the trial registrant

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

Benign prostatic hyperplasia

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Northwell Health

    Syosset, New York, 11791, United States

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