Actively Recruiting
A Prospective, Multicenter, Double Blind, Randomized Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Led by Rivermark Medical · Updated on 2025-04-27
215
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the FloStent, a medical device designed to treat men with symptoms of Benign Prostatic Hyperplasia (BPH). The study is a randomized, double-blind clinical trial comparing the FloStent to a sham procedure without device deployment. It focuses on men aged 45 years and older who experience urinary symptoms related to BPH. Participants will undergo a flexible cystoscopy procedure. Those assigned 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 being deployed. The study involves close monitoring over a 12-month period to assess changes in urinary symptoms. Throughout the study, participants will be evaluated using the International Prostate Symptom Score (IPSS) at various intervals, including 3, 6, and 12 months. This scoring system helps measure symptom changes over time. Researchers will also monitor safety and treatment responses. Participants can expect scheduled visits and assessments to track outcomes related to urinary function and device safety during the study duration.
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
Eligibility Criteria
You may qualify if you...
- Male subjects older than 45 years with symptomatic Benign Prostatic Hyperplasia
- International Prostate Symptom Score (IPSS) greater than 13
- Peak urinary flow rate between 5 and 13 mL/sec with 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 scheduled visits
You will not qualify if you...
- Presence of an artificial urinary sphincter or urethral or prostate stents
- Prior minimally invasive or surgical intervention on the prostate or urethra
- Prostate-specific antigen (PSA) level greater than 10 ng/mL
- History of bladder cancer or bladder stones
- Active urinary tract infection
- Uncontrolled diabetes
- Being part of a vulnerable population such as cognitively challenged individuals or incarcerated persons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure visit
Participants undergo a flexible cystoscopy procedure with either the FloStent implant deployed or a sham procedure without the implant.
1 visit (in-person)
Duration - 12 months
Participants are monitored for safety and efficacy outcomes, including changes in symptom scores over 12 months.
Multiple follow-up visits during 12 months
Trial Site Locations
Total: 20 locations
1
Michael G Oefelein Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
2
Comprehensive Urology Medical Group
Beverly Hills, California, United States, 90048
Actively Recruiting
3
Atlas Men's Health
La Mesa, California, United States, 91942
Actively Recruiting
4
Urology Group of Southern California
Los Angeles, California, United States, 90017
Actively Recruiting
5
Prestige Medical Group
Tustin, California, United States, 92780
Actively Recruiting
6
Urology Denver
Littleton, Colorado, United States, 80122
Actively Recruiting
7
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
Actively Recruiting
8
Duly Health
Lisle, Illinois, United States, 60532
Actively Recruiting
9
Loyola Medicine
Maywood, Illinois, United States, 60153
Not Yet Recruiting
10
Southern Urology
Lafayette, Louisiana, United States, 70508
Actively Recruiting
11
Michigan Institute of Urology
Troy, Michigan, United States, 48084
Actively Recruiting
12
Sheldon Freedman Urology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
13
Manhattan Medical Research NYU Langone
New York, New York, United States, 10016
Actively Recruiting
14
Northwell Health
Syosset, New York, United States, 11791
Not Yet Recruiting
15
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
16
Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
17
Midtown Urology Associates
Austin, Texas, United States, 78705
Actively Recruiting
18
Urology Austin/Urology America
Austin, Texas, United States, 78759
Actively Recruiting
19
Houston Methodist
Houston, Texas, United States, 77030
Not Yet Recruiting
20
South Coast Urology
Wollongong, New South Wales, Australia, 2500
Not Yet Recruiting
Research Team
S
Study Manager Study Director, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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