Trials Today

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

Purpose

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.

Condition

Benign Prostatic Hyperplasia

Eligibility

Eligible Ages: Over 45 Years
Eligible Sex: Male
Accepts 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)

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 2:1 (device:sham) ratio .
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment - FloStent	Flexible cystoscopy procedure with FloStent implant deployed	Device: FloStent Flexible cystoscopy to deploy medical device used to treat BPH
Sham Comparator Sham Control	Flexible cystoscopy procedure without FloStent implant deployed	Device: Sham (Control) Flexible Cystoscopy without deployment of medical device used to treat BPH

Recruiting Locations

Michael G Oefelein Clinical Trials
Bakersfield 5325738, California 5332921 93301

Comprehensive Urology Medical Group
Beverly Hills 5328041, California 5332921 90048

Atlas Men's Health
La Mesa 5363990, California 5332921 91942

Urology Group of Southern California
Los Angeles 5368361, California 5332921 90017

Prestige Medical Group
Tustin 5404119, California 5332921 92780

Urology Denver
Littleton 5429032, Colorado 5417618 80122

Advanced Urology Institute
Daytona Beach 4152872, Florida 4155751 32114

Duly Health
Lisle 4900080, Illinois 4896861 60532

Southern Urology
Lafayette 4330145, Louisiana 4331987 70508

Michigan Institute of Urology
Troy 5012639, Michigan 5001836 48084

Sheldon Freedman Urology
Las Vegas 5506956, Nevada 5509151 89144

Manhattan Medical Research NYU Langone
New York 5128581, New York 5128638 10016

Associated Urologists of North Carolina
Raleigh 4487042, North Carolina 4482348 27612

Conrad Pearson Clinic
Germantown 4624601, Tennessee 4662168 38138

Midtown Urology Associates
Austin 4671654, Texas 4736286 78705

Urology Austin/Urology America
Austin 4671654, Texas 4736286 78759

More Details

NCT ID: NCT06849258
Status: Recruiting
Sponsor: Rivermark Medical

Study Contact

Study Manager Study Director, MD
414-758-7948
info@rivermarkmedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.