OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Last updated: March 7, 2025
Sponsor: Urotronic Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Disorders

Prostate Disorders

Treatment

Data collection

Clinical Study ID

NCT06560476
PR1326
  • Male

Study Summary

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients treated with the Optilume BPH Catheter System in accordance with theInstructions for Use (IFU).

Exclusion

Exclusion Criteria:

  1. Unwilling to abstain from sexual intercourse or use a condom for 30 dayspost-procedure and utilize a highly effective contraceptive for at least 12 monthspost-procedure

  2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in theurethra or prostate

  3. Confirmed or suspected malignancy of prostate or bladder.

  4. Active urinary tract infection (UTI)

  5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable fortreatment with the Optilume BPH Catheter System

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
March 30, 2024
Estimated Completion Date:
March 30, 2027

Connect with a study center

  • Golden State Urology

    Sacramento, California 95823
    United States

    Active - Recruiting

  • Florida Urology Partners

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Kearney Urology Center

    Kearney, Nebraska 68847
    United States

    Active - Recruiting

  • Adult & Pediatric Urology, PC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Adult & Pediatric Uroology, PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Sheldon Freedman, Ltd

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

  • Northwell Health - Smith Institute of Urology

    Syosset, New York 11791
    United States

    Active - Recruiting

  • Good Samaritan Hospital

    Corvallis, Oregon 97330
    United States

    Active - Recruiting

  • Potomac Urology

    Woodridge, Virginia 22191
    United States

    Active - Recruiting

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