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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study 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.

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

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

Condition
Benign Prostatic Hyperplasia
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Michael G Oefelein Clinical Trials, Bakersfield, California, United States, 93301

Beverly Hills

Comprehensive Urology Medical Group, Beverly Hills, California, United States, 90048

La Mesa

Atlas Men's Health, La Mesa, California, United States, 91942

Los Angeles

Urology Group of Southern California, Los Angeles, California, United States, 90017

Littleton

Urology Denver, Littleton, Colorado, United States, 80122

Daytona Beach

Advanced Urology Institute, Daytona Beach, Florida, United States, 32114

Lisle

Duly Health, Lisle, Illinois, United States, 60532

Maywood

Loyola Medicine, Maywood, Illinois, United States, 60153

Lafayette

Southern Urology, Lafayette, Louisiana, United States, 70508

Troy

Michigan Institute of Urology, Troy, Michigan, United States, 48084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rivermark Medical,

Study Director, MD, STUDY_DIRECTOR, Rivermark Medical, Inc.

Study Record Dates

2032-12-31