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Clinical Trials in Australia / NCT06849258
Recruiting Not applicable

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

NCT06849258 · tracked via the Priya Life Science Australia tracker
Sponsor
Rivermark Medical
Phase
Not applicable
Started
2025-02-10
Last updated
2026-06-11

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

FloStentSham (Control)

FloStent: Flexible cystoscopy to deploy medical device used to treat BPH

Sham (Control): Flexible Cystoscopy without deployment of medical device used to treat BPH

Study summary

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.

Eligibility

Sex
MALE
Min age
45 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Change in International Prostate Symptom Score (IPSS) — 12 months
    The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL). The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic

Trial sites (20)

FacilityCityRegionStatus
Michael G Oefelein Clinical Trials Bakersfield California Recruiting
Comprehensive Urology Medical Group Beverly Hills California Recruiting
Atlas Men's Health La Mesa California Recruiting
Urology Group of Southern California Los Angeles California Recruiting
Alarcon Urology Center Montebello California Recruiting
Prestige Medical Group Tustin California Recruiting
Urology Denver Littleton Colorado Recruiting
Advanced Urology Institute Daytona Beach Florida Recruiting
Duly Health Lisle Illinois Recruiting
Southern Urology Lafayette Louisiana Recruiting
Michigan Institute of Urology Troy Michigan Recruiting
Sheldon Freedman Urology Las Vegas Nevada Recruiting
Manhattan Medical Research NYU Langone New York New York Recruiting
Northwell Health Syosset New York Recruiting
Associated Urologists of North Carolina Raleigh North Carolina Recruiting
Conrad Pearson Clinic Germantown Tennessee Recruiting
Midtown Urology Associates Austin Texas Recruiting
Urology Austin/Urology America Austin Texas Recruiting
Houston Methodist Houston Texas Recruiting
South Coast Urology Wollongong New South Wales Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06849258 on ClinicalTrials.gov ↗ ← All trials in Australia