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

Rivermark Medical · NCT06849258

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45+ · Men only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
215
US sites recruiting
19
Study start
February 10, 2025
Record last updated
June 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

Being studied: FloStent; Sham (Control)

Conditions: Benign Prostatic Hyperplasia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

Study contacts (from the official record)

  • Study Manager Study Director, MD · 414-758-7948 · info@rivermarkmedical.com
A Clinical Study to Evaluate the Safety and Efficacy of the… (NCT06849258) | Bored Studies