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

Description

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

Conditions

Benign Prostatic Hyperplasia

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Study Overview

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Study Details

Study 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.

A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

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

Condition
Benign Prostatic Hyperplasia
Intervention / Treatment

-

Contacts and Locations

Kearney

Kearney Urology Center, Kearney, Nebraska, United States, 68847

Omaha

Adult & Pediatric Urology, PC, Omaha, Nebraska, United States, 68144

Corvallis

Good Samaritan Hospital, Corvallis, Oregon, United States, 97330

Woodridge

Potomac Urology, Woodridge, Virginia, United States, 22191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Urotronic Inc.,

Study Record Dates

2027-03-30