Clinical trial NCT06849258: A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
Official title: A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia
FloStent
Rivermark Medical
BPH
LUTS
Lower urinary tract symptoms
enlarged prostate
Lead sponsor: Rivermark Medical
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 215
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a 2:1 (device:sham) ratio .
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: 12 months
Secondary outcomes:
measure: Percent responders to IPSS
timeFrame: 3 months
measure: Percent responders to IPSS
timeFrame: 6 months
measure: Percent responders to IPSS
timeFrame: 12 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Michael G Oefelein Clinical Trials
state: California
city: Beverly Hills
country: United States
facility: Comprehensive Urology Medical Group
state: California
city: La Mesa
country: United States
facility: Atlas Men's Health
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Tustin
country: United States
facility: Prestige Medical Group
state: California
city: Littleton
country: United States
facility: Urology Denver
state: Colorado
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Lisle
country: United States
facility: Duly Health
state: Illinois
city: Maywood
country: United States
facility: Loyola Medicine
state: Illinois
city: Lafayette
country: United States
facility: Southern Urology
state: Louisiana
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Las Vegas
country: United States
facility: Sheldon Freedman Urology
state: Nevada
city: New York City
country: United States
facility: Manhattan Medical Research NYU Langone
state: New York
city: Syosset
country: United States
facility: Northwell Health
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Germantown
country: United States
facility: Conrad Pearson Clinic
state: Tennessee
city: Austin
country: United States
facility: Midtown Urology Associates
state: Texas
city: Austin
country: United States
facility: Urology Austin/Urology America
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Wollongong
country: Australia
facility: South Coast Urology
state: New South Wales
Study officials:
affiliation: Rivermark Medical, Inc.
name: Study Director, MD
role: STUDY_DIRECTOR
References: