Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
ConditionBenign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUrotronic Inc.
About this trial
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Eligibility criteria
Qualifiers
Male subject ≥ 50 years old
Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
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
Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA < 25%.
Trial design
Treatments tested in this trial
- Optilume® BPH Catheter System
Treatment groups
92 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov