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

January 12, 2026 updated by: Urotronic Inc.
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

STUDY ENDPOINTS

Primary Efficacy Endpoint:

The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.

Primary Safety Endpoint:

The primary safety endpoint is the freedom from composite treatment-related adverse SAEs.

Key Secondary Safety Endpoint (Semen Sub-Study Only):

The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).

Ancillary Endpoints:

Ancillary Safety Endpoint:

  1. Frequency and severity of treatment-related AEs 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. An independent medical monitor will adjudicate all treatment-related events.
  2. Frequency and severity of all AEs All adverse events will be summarized and reported, regardless of relatedness to the device or procedure.
  3. Change from baseline in semen characteristics over time (semen sub-study only) Semen characteristics (concentration, count, motility) will be summarized at each follow-up, including change from baseline values. Reported values for each subject will represent an average of 2 samples collected at each timepoint. Summary statistics will be based on reported values for each subject at each timepoint.

  4. Proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline The proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline to 3, 6 and 12 months will be reported.

    Ancillary Efficacy Endpoints:

  5. Improvement in IPSS over time 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.
  6. Improvement in ICS male SF over time The International Continence Society (ICS) male short form (SF) has three domains to assess urinary symptoms; voiding symptoms (e.g., hesitancy, incomplete voiding, etc.), storage symptoms (e.g., frequency), and leakage symptoms. Average total scores and average scores for each domain, along with changes from baseline, will be reported at each follow-up timepoint.
  7. Improvement in Qmax over time 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.
  8. Improvement in PVR over time 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.
  9. Freedom from repeat intervention (time-to-event) The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology
        • Contact:
        • Principal Investigator:
          • Jeffrey Marotte, MD
    • Florida
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Florida Urology Partners, LLP
        • Contact:
        • Principal Investigator:
          • Osvaldo Padron, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Recruiting
        • Ochsner LSU Health Shreveport - Regional Urology
        • Principal Investigator:
          • Jared Moss, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Sheldon Freedman MD, Ltd
        • Contact:
        • Principal Investigator:
          • Sheldon Freedman, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Midtown Urology Associates
        • Contact:
        • Principal Investigator:
          • Michael Trotter, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male subject ≥ 50 years old
  2. Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
  3. Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
  4. Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
  5. International Prostate Symptom Score (IPSS) ≥ 13
  6. Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
  7. Willing to provide informed consent and comply with protocol required follow-up

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. Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
  4. 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%.
  5. Active urinary tract infection (UTI) confirmed by culture
  6. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
  7. History of overt urinary incontinence requiring the use of pads
  8. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
  9. Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage
  10. Known poor detrusor muscle function (e.g., Qmax < 5 mL/sec)
  11. Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
  12. Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
  13. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
  14. Obstructive median lobe in the opinion of the investigator

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Arm
Optilume BPH Catheter System
Device: Optilume® BPH Catheter System
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: Baseline to 12 months

The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.

The first seven questions in the International Prostate Symptom Score (IPSS) questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Baseline to 12 months
Rate of a composite of treatment-related serious adverse events (SAEs)
Time Frame: 3 months

The primary safety endpoint is the rate of a composite of the specified treatment-related serious adverse events through 3 months post-treatment:

  • De novo severe urinary retention lasting >14 days post-procedure
  • De novo severe stress urinary incontinence requiring surgical management
  • Formation of a fistula between the rectum and urethra
  • Perforation of the rectum or GI tract
  • Bleeding requiring transfusion or endoscopic intervention
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sperm Concentration
Time Frame: Baseline to 3 months
For the Semen Sub-Study, the average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).
Baseline to 3 months

Collaborators and Investigators

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

Sponsor

Urotronic Inc.

Investigators

  • Principal Investigator: Steven Kaplan, MD, FACS, Professor of Urology

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)

February 7, 2024

Primary Completion (Estimated)

February 7, 2031

Study Completion (Estimated)

February 7, 2031

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR1309

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

Yes

product manufactured in and exported from the U.S.

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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