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Could a tiny stent replace pills for prostate trouble?

NCT ID NCT06849258

Symptom relief Sponsor: Rivermark Medical Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called FloStent, a small tube placed in the prostate to help urine flow more easily in men with an enlarged prostate (benign prostatic hyperplasia). About 215 men with moderate to severe symptoms will either get the FloStent or a sham procedure where nothing is placed. Researchers will measure changes in urinary symptoms and quality of life over time.

What this could mean

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

Active substance
FloStent (a stent placed in the prostate to keep the urethra open)
What this could lead to
If it works, this could offer a new, less invasive option for men with enlarged prostate to improve urinary symptoms without daily medication or major surgery.
What could go wrong
This is an early-stage device trial, so it may not prove more effective than a sham procedure. Risks include discomfort, infection, or the device moving out of place.

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 215 people

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

Started

Feb 2025

Expected to finish

Dec 2032

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 subjects \> 45 years of age who have symptomatic BPH * International Prostate Symptom Score (IPSS) score \>13 * Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL * Post-void residual (PVR) \<250 mL * Prostate volume 25 to 80 mL * Prostatic urethral length 20-50 mm * Able to complete the study protocol and visits Exclusion Criteria: * Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate * Prior minimally invasive intervention or surgical intervention of the prostate or urethra * PSA \>10 ng/mL * Bladder cancer or bladder stones * Active urinary tract infection (UTI) * Uncontrolled diabetes * Part of a vulnerable population (cognitively challenged or are incarcerated)

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Urology Institute

    RECRUITING

    Daytona Beach, Florida, 32114, United States

  • Alarcon Urology Center

    RECRUITING

    Montebello, California, 90640, United States

  • Associated Urologists of North Carolina

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Atlas Men's Health

    RECRUITING

    La Mesa, California, 91942, United States

  • Comprehensive Urology Medical Group

    RECRUITING

    Beverly Hills, California, 90048, United States

  • Conrad Pearson Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Duly Health

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Manhattan Medical Research NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Michael G Oefelein Clinical Trials

    RECRUITING

    Bakersfield, California, 93301, United States

  • Michigan Institute of Urology

    RECRUITING

    Troy, Michigan, 48084, United States

  • Midtown Urology Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • Northwell Health

    RECRUITING

    Syosset, New York, 11791, United States

  • Prestige Medical Group

    RECRUITING

    Tustin, California, 92780, United States

  • Sheldon Freedman Urology

    RECRUITING

    Las Vegas, Nevada, 89144, United States

  • South Coast Urology

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Southern Urology

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Urology Austin/Urology America

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology Denver

    RECRUITING

    Littleton, Colorado, 80122, United States

  • Urology Group of Southern California

    RECRUITING

    Los Angeles, California, 90017, United States

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