OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH (APEX)

Urotronic

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT06560476

PR1326

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Study Arm

Description:

This is the data collection study arm. There is no other arm in the study.

Treatment:

Other: Data collection