OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH (APEX)

March 23, 2026 updated by: Urotronic Inc.

A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95823
        • Withdrawn
        • Golden State Urology
    • Florida
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Florida Urology Partners
        • Principal Investigator:
          • Osvaldo Padron, MD
        • Sub-Investigator:
          • Alonso Alvarez, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Stephanie Stillings, MD
    • Nebraska
      • Kearney, Nebraska, United States, 68847
      • Omaha, Nebraska, United States, 68144
        • Completed
        • The Urology Center, P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Sheldon Freedman, Ltd
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sheldon Freedman, MD
    • New York
      • Syosset, New York, United States, 11791
        • Recruiting
        • Northwell Health - Smith Institute of Urology
        • Contact:
        • Principal Investigator:
          • Chughtai, MD
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Completed
        • Good Samaritan Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Midtown Urology
        • Principal Investigator:
          • Tyler McClintock, MD
        • Contact:
    • Virginia
      • Woodridge, Virginia, United States, 22191
        • Completed
        • Potomac Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Arm
This is the data collection study arm. There is no other arm in the study.
Other: Data collection
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
Time Frame: 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.
Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Time Frame: Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of treatment-related AEs
Time Frame: From baseline to through study completion, an average of 2 years.
Adverse events will be collected and assessed for relatedness to the device and the procedure as well as for severity. The Clavien-Dindo severity grading scale is a commonly used criteria in the urology community.
From baseline to through study completion, an average of 2 years.
Change in IPSS over time
Time Frame: From baseline to through study completion, an average of 2 years.

The IPSS tool is the most commonly reported symptom score for obstructive urinary symptoms secondary to BPH. Average IPSS scores, absolute change from baseline, and percent change from baseline will be reported at each follow-up timepoint.

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.
From baseline to through study completion, an average of 2 years.
Change in Qmax (mL per second) over time
Time Frame: From baseline to through study completion, an average of 2 years.

Uroflowmetry represents an objective measure of relief of obstruction. Average peak urinary flow rate (Qmax) and change from baseline will be reported at each follow-up timepoint.

Uroflowmetry assesses flow pattern, flow curve shape, maximum urinary flow (Qmax), voided volume (VV), voiding time (VT), PVR volume (PVR). A minimum of 150ml is required to provide an accurate assessment in men
From baseline to through study completion, an average of 2 years.
Change in PVR over time
Time Frame: From baseline to through study completion, an average of 2 years.

Residual urine in the bladder due to incomplete emptying is an important clinical consideration in subjects with obstructive BPH. Average PVR and change from baseline will be reported at each follow-up timepoint.

Post-void residual volume (PVR) is the amount of urine retained in the bladder after a voluntary void and functions as a diagnostic tool. A PVR can be used to assess many disease processes, including but not limited to neurogenic bladder, cauda equina syndrome, urinary outlet obstruction, mechanical obstruction, medication-induced urinary retention, postoperative urinary retention, and urinary tract infections. The PVR may be determined through urinary catheterization, a portable dedicated bladder scanner, or a formal ultrasound examination.
From baseline to through study completion, an average of 2 years.
Freedom from repeat intervention (time-to-event)
Time Frame: From baseline to through study completion, an average of 2 years.
The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.
From baseline to through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urotronic Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR1326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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