OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
ConditionBenign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorUrotronic Inc.
About this trial
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
Qualifiers
None
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Data collection
Treatment groups
500 Participants
are divided into 1 treatment groupLocations
9California
Golden State Urology95823, Sacramento United States
Florida
Florida Urology Partners33615, Tampa United States
Nebraska
Kearney Urology Center68847, Kearney United States
The Urology Center, P.C.68144, Omaha United States
Sponsors and collaborators
Urotronic Inc.
Lead sponsor
Source ClinicalTrials.gov