A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FloStent, Sham (Control).
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device FloStent
Flexible cystoscopy to deploy medical device used to treat BPH - Device Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Primary outcome measures
- Change in International Prostate Symptom Score (IPSS) [Time frame: 12 months]
Secondary outcome measures (3)
- Percent responders to IPSS [Time frame: 3 months]
- Percent responders to IPSS [Time frame: 6 months]
- Percent responders to IPSS [Time frame: 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Michael G Oefelein Clinical Trials — Bakersfield
- Comprehensive Urology Medical Group — Beverly Hills
- Atlas Men's Health — La Mesa
- Urology Group of Southern California — Los Angeles
- Alarcon Urology Center — Montebello
- Prestige Medical Group — Tustin
- Urology Denver — Littleton
- Advanced Urology Institute — Daytona Beach
- … and 11 more centers
Australia · 1 center
- South Coast Urology — Wollongong
Identifiers
NCT: NCT06849258 · C0002 Rev. 07