Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Key facts

Study ID

NCT06312722

Run by

Urotronic Inc.

People needed

92

Starts

2024-02-07

Expected to finish

2031-02-07

Last updated by the study team

2026-07-10

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• International Prostate Symptom Score (IPSS) ≥ 13
• Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
• Willing to provide informed consent and comply with protocol required follow-up

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
• 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%.
• Active urinary tract infection (UTI) confirmed by culture
• Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
• History of overt urinary incontinence requiring the use of pads
• Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
• Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage
• Known poor detrusor muscle function (e.g., Qmax < 5 mL/sec)
• Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
• Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
• Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
• Obstructive median lobe in the opinion of the investigator

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• Florida Urology Partners, LLP — Tampa, Florida, United States (enrolling)
• Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States (enrolling)
• Sheldon Freedman MD, Ltd — Las Vegas, Nevada, United States (enrolling)
• Oregon Urology Institute — Springfield, Oregon, United States (enrolling)
• Midtown Urology Associates — Austin, Texas, United States (enrolling)
• Houston Methodist Urology Associates — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.