Actively Recruiting
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Led by Urotronic Inc. · Updated on 2026-01-14
92
Participants Needed
5
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
CONDITIONS
Official Title
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subject 50 years old or older
- Diagnosed with lower urinary tract symptoms due to obstructive benign prostatic hyperplasia
- Eligible for treatment with the Optilume BPH Catheter System following the Instructions for Use
- Prostate volume less than 80 g and prostatic urethral length between 32-55 mm by trans-rectal ultrasound
- International Prostate Symptom Score (IPSS) of 13 or higher
- Peak urinary flow rate (Qmax) between 5 and 15 mL/sec with a minimum voided volume of 125 mL
- Willing to provide informed consent and follow study requirements
You will not qualify if you...
- Unwilling to abstain from sexual intercourse or use a condom for 30 days after the procedure and to use effective contraception for at least 12 months
- Presence of artificial urinary sphincter, penile prosthesis, or urethral or prostate stents
- Prior minimally invasive or surgical intervention of the prostate
- Confirmed or suspected prostate or bladder cancer; negative prostate biopsy required within 6 months if PSA > 4 ng/mL with free PSA < 25%
- Active urinary tract infection confirmed by culture
- Neurogenic bladder, sphincter abnormalities, or neurological disorders affecting bladder function
- History of significant urinary incontinence requiring pads
- Diagnosis of urethral strictures, bladder neck contracture, or detrusor muscle spasms
- Post-void residual urine volume greater than 300 mL or catheter-dependent bladder drainage
- Poor detrusor muscle function (Qmax less than 5 mL/sec)
- Active bladder, ureteral, or urethral stones or recent stone passage within 3 months
- Poorly controlled diabetes (hemoglobin A1c ≥ 8%)
- Anatomy unsuitable for treatment with the Optilume BPH Catheter System
- Presence of obstructive median lobe as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Florida Urology Partners, LLP
Tampa, Florida, United States, 33615
Actively Recruiting
3
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, United States, 71106
Actively Recruiting
4
Sheldon Freedman MD, Ltd
Las Vegas, Nevada, United States, 89144
Actively Recruiting
5
Midtown Urology Associates
Austin, Texas, United States, 78705
Actively Recruiting
Research Team
J
Jill Moland
CONTACT
B
Brandon Shuler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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