Recruiting

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

Sponsor:

Rivermark Medical

Code:

NCT06849258

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

FloStent

Sham (Control)

Study Details

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Study ID

NCT06849258

Start date

Feb 10, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2032

Anticipated

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment - FloStent

Flexible cystoscopy procedure with FloStent implant deployed

sham comparator: Sham Control

Flexible cystoscopy procedure without FloStent implant deployed

Interventions

FloStent

Flexible cystoscopy to deploy medical device used to treat BPH

Sham (Control)

Flexible Cystoscopy without deployment of medical device used to treat BPH

Primary outcome measure

Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Study Manager Study Director, MD

414-758-7948 info@rivermarkmedical.com

Locations

Michael G Oefelein Clinical Trials

Recruiting

Bakersfield, California, United States, 93301

Comprehensive Urology Medical Group

Recruiting

Beverly Hills, California, United States, 90048

Atlas Men's Health

Recruiting

La Mesa, California, United States, 91942

Urology Group of Southern California

Recruiting

Los Angeles, California, United States, 90017

Alarcon Urology Center

Recruiting

Montebello, California, United States, 90640

Prestige Medical Group

Recruiting

Tustin, California, United States, 92780

Urology Denver

Recruiting

Littleton, Colorado, United States, 80122

Advanced Urology Institute

Recruiting

Daytona Beach, Florida, United States, 32114

Duly Health

Recruiting

Lisle, Illinois, United States, 60532

Southern Urology

Recruiting

Lafayette, Louisiana, United States, 70508

Michigan Institute of Urology

Recruiting

Troy, Michigan, United States, 48084

Sheldon Freedman Urology

Recruiting

Las Vegas, Nevada, United States, 89144

Manhattan Medical Research NYU Langone

Recruiting

New York, New York, United States, 10016

Northwell Health

Recruiting

Syosset, New York, United States, 11791

Associated Urologists of North Carolina

Recruiting

Raleigh, North Carolina, United States, 27612

Conrad Pearson Clinic

Recruiting

Germantown, Tennessee, United States, 38138

Midtown Urology Associates

Recruiting

Austin, Texas, United States, 78705

Urology Austin/Urology America

Recruiting

Austin, Texas, United States, 78759

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Rivermark Medical

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

benign prostatic hyperplasia
FloStent
Rivermark Medical
BPH
LUTS
Lower urinary tract symptoms
enlarged prostate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rivermark Medical on 2026-06-11.