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

NCT06849258 | Recruiting DMC FDA Device

• 1 other identifier: C0002 Rev. 07
• Study Type: interventional
• Target: 215
• Locations: 2 countries
• Sites: 20

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia; FloStent; Rivermark Medical; BPH; LUTS; Lower urinary tract symptoms; enlarged prostate

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL). The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic

  12 months

Secondary Outcomes (3)

• Percent responders to IPSS

  3 months

• Percent responders to IPSS

  6 months

• Percent responders to IPSS

  12 months

Study Arms (2)

Treatment - FloStent

EXPERIMENTAL

Flexible cystoscopy procedure with FloStent implant deployed

Device: FloStent

Sham Control

SHAM COMPARATOR

Flexible cystoscopy procedure without FloStent implant deployed

Device: Sham (Control)

Interventions

FloStent DEVICE

Flexible cystoscopy to deploy medical device used to treat BPH

Treatment - FloStent

Sham (Control) DEVICE

Flexible Cystoscopy without deployment of medical device used to treat BPH

Sham Control

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Male at birth and identify as male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rivermark Medical: lead

Study Sites (20)

Michael G Oefelein Clinical Trials

Bakersfield, California, 93301, United States

RECRUITING

Comprehensive Urology Medical Group

Beverly Hills, California, 90048, United States

RECRUITING

Atlas Men's Health

La Mesa, California, 91942, United States

RECRUITING

Urology Group of Southern California

Los Angeles, California, 90017, United States

RECRUITING

Prestige Medical Group

Tustin, California, 92780, United States

RECRUITING

Urology Denver

Littleton, Colorado, 80122, United States

RECRUITING

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

RECRUITING

Duly Health

Lisle, Illinois, 60532, United States

RECRUITING

Loyola Medicine

Maywood, Illinois, 60153, United States

NOT YET RECRUITING

Southern Urology

Lafayette, Louisiana, 70508, United States

RECRUITING

Michigan Institute of Urology

Troy, Michigan, 48084, United States

RECRUITING

Sheldon Freedman Urology

Las Vegas, Nevada, 89144, United States

RECRUITING

Manhattan Medical Research NYU Langone

New York, New York, 10016, United States

RECRUITING

Northwell Health

Syosset, New York, 11791, United States

NOT YET RECRUITING

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

RECRUITING

Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Midtown Urology Associates

Austin, Texas, 78705, United States

RECRUITING

Urology Austin/Urology America

Austin, Texas, 78759, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

NOT YET RECRUITING

South Coast Urology

Wollongong, New South Wales, 2500, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director, MD

  Rivermark Medical, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Manager Study Director, MD

CONTACT

414-758-7948; info@rivermarkmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 2:1 (device:sham) ratio .

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 27, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); AU (1)