Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT06560476
Active, not recruiting Observational

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

NCT06560476 · tracked via the Priya Life Science USA tracker
Sponsor
Urotronic Inc
Phase
Observational
Started
2024-03-30
Last updated
2026-07-10

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Data collection

Data collection: Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

Study summary

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

Sex
MALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1\. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU). Exclusion Criteria: 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

Primary outcome measure(s)

  • The primary efficacy endpoint is the average IPSS change from baseline to 12 months. — Baseline to 12 months
    The primary efficacy endpoint is the average IPSS change from baseline to 12 months. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
  • The primary safety endpoint is the freedom from treatment-related adverse SAEs. — Baseline to 12 months
    The primary safety endpoint is the freedom from treatment-related adverse SAEs.

Trial sites (8)

FacilityCityRegionStatus
Florida Urology Partners Tampa Florida
Kearney Urology Center Kearney Nebraska
The Urology Center, P.C. Omaha Nebraska
Sheldon Freedman, Ltd Las Vegas Nevada
Northwell Health - Smith Institute of Urology Syosset New York
Good Samaritan Hospital Corvallis Oregon
Midtown Urology Austin Texas
Potomac Urology Woodridge Virginia

More Urotronic Inc. trials in the USA

Optilume™ BPH Catheter System in Men With Symptomatic BPH Active, not recruiting
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters Active, not recruiting
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures Recruiting
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease Active, not recruiting
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study Recruiting

Other trials for the same condition

Comparing UroLift Experience Against Rezūm Active, not recruiting
Optilume™ BPH Catheter System in Men With Symptomatic BPH Active, not recruiting
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms Recruiting
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs Active, not recruiting
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06560476 on ClinicalTrials.gov ↗ ← All trials in the USA