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

NCT06312722 | Recruiting DMC FDA Device

• 1 other identifier: PR1309
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Change in International Prostate Symptom Score (IPSS)

  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)

  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 Outcomes (1)

• Change in Sperm Concentration

  Baseline to 3 months

Study Arms (1)

Study Arm

OTHER

Optilume BPH Catheter System

Device: Optilume® BPH Catheter System

Interventions

Optilume® BPH Catheter System DEVICE

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.

Study Arm

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: BPH is a disease of the prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Urotronic Inc.: lead

Study Sites (5)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

RECRUITING

Florida Urology Partners, LLP

Tampa, Florida, 33615, United States

RECRUITING

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

RECRUITING

Sheldon Freedman MD, Ltd

Las Vegas, Nevada, 89144, United States

RECRUITING

Midtown Urology Associates

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Steven Kaplan, MD, FACS

  Professor of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Moland

CONTACT

612-245-6434; jmoland@laborie.com

Brandon Shuler

CONTACT

701-220-1710; bshuler@laborie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, multi-center, post market clinical trial

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): February 7, 2031
• Study Completion (Estimated): February 7, 2031
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)