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

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

Recruiting
Male
Phase N/A
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Overview

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
  2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra 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 for treatment with the Optilume BPH Catheter System

Study details
    Benign Prostatic Hyperplasia

NCT06560476

Urotronic Inc.

15 October 2025

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