What is FloStent studying for Benign Prostatic Hyperplasia?

FloStent is being studied to evaluate its safety and effectiveness in treating urinary symptoms caused by Benign Prostatic Hyperplasia in men. This trial compares the FloStent device implanted via cystoscopy with a sham procedure to understand its impact on symptoms. The study is sponsored by Rivermark Medical and aims to provide important information for men with BPH.

Who may be eligible for this Benign Prostatic Hyperplasia clinical trial?

Men aged 45 years or older with symptomatic Benign Prostatic Hyperplasia and an International Prostate Symptom Score above 13 may be eligible. Participants must have specific urinary flow rates and prostate measurements and be able to complete study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this Benign Prostatic Hyperplasia clinical trial?

Study-related care, including the cystoscopy procedure and device or sham treatment, along with all trial visits, is provided at no cost. Personal travel expenses vary and may not be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 45Years +

MALE

ID06849258

Study to Test the Safety and Effectiveness of the FloStent Device in Men Over 45 With Benign Prostatic Hyperplasia Symptoms

Led by Rivermark Medical · Updated on 2026-06-11

215

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the FloStent, a medical device used for treating men experiencing symptoms of Benign Prostatic Hyperplasia BPH. The study compares the FloStent implant procedure to a sham procedure without deploying the device. It involves men aged 45 and older with symptomatic BPH to better understand how this device may impact urinary symptoms. Participants will undergo a flexible cystoscopy procedure. Those randomized to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant deployment, serving as a sham treatment. The study is randomized, double-blind, and includes parallel groups to compare outcomes over time. Throughout the study, participants will be assessed on changes in their International Prostate Symptom Score IPSS over 12 months. Researchers will monitor symptom improvements at 3, 6, and 12 months to evaluate response rates. Participants will complete study visits and follow the protocol to help researchers gather data on the devices safety and impact on urinary symptoms.

CONDITIONS

Brief Title

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

Who Can Participate

Age: 45Years +

MALE

Eligibility Criteria

You may qualify if you...

Male subjects over 45 years of age who have symptomatic BPH
International Prostate Symptom Score (IPSS) score greater than 13
Peak urinary flow rate between greater than 5 mL/sec and less than 13 mL/sec with a minimum voided volume over 125 mL
Post-void residual volume less than 250 mL
Prostate volume between 25 and 80 mL
Prostatic urethral length between 20 and 50 mm
Able to complete the study protocol and visits

You will not qualify if you...

Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
Prior minimally invasive or surgical intervention of the prostate or urethra
Prostate-specific antigen (PSA) greater than 10 ng/mL
Bladder cancer or bladder stones
Active urinary tract infection (UTI)
Uncontrolled diabetes
Part of a vulnerable population such as cognitively challenged individuals or those who are incarcerated

Research Team

Study Manager Study Director, MD

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