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

Running, not enrolling

Conditions studied: Benign Prostatic Hyperplasia

In brief

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

Key facts

Study ID

NCT06560476

Run by

Urotronic Inc.

People needed

500

Starts

2024-03-30

Expected to finish

2027-03-30

Last updated by the study team

2026-07-10

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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
• Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
• Confirmed or suspected malignancy of prostate or bladder.
• Active urinary tract infection (UTI)
• Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

Where it is running

• Florida Urology Partners — Tampa, Florida, United States
• Kearney Urology Center — Kearney, Nebraska, United States
• The Urology Center, P.C. — Omaha, Nebraska, United States
• Sheldon Freedman, Ltd — Las Vegas, Nevada, United States
• Northwell Health - Smith Institute of Urology — Syosset, New York, United States
• Good Samaritan Hospital — Corvallis, Oregon, United States
• Midtown Urology — Austin, Texas, United States
• Potomac Urology — Woodridge, Virginia, United States

Full record on ClinicalTrials.gov

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