Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

NCT03423979 | Completed Phase 2 Results FDA Device

• 1 other identifier: PR1051
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 5

Brief Summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Conditions

Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Keywords

BPH

Outcome Measures

Primary Outcomes (2)

• Therapeutic Responder at 3 Months

  The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS 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.

  90 days

• Major Device/Procedure Related Complications

  The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.

  90 days

Study Arms (1)

Optilume™ BPH Prostatic DCB Dilation Catheter

EXPERIMENTAL

Optilume™ BPH Prostatic DCB treatment procedure

Device: Optilume™ BPH Prostatic DCB Dilation Catheter; Drug: Paclitaxel

Interventions

Optilume™ BPH Prostatic DCB Dilation Catheter DEVICE

BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).

Also known as: BPH Prostatic DCB

Optilume™ BPH Prostatic DCB Dilation Catheter

Paclitaxel DRUG

paclitaxel will release to adjacent tissue after the balloon inflated in the urethra

Also known as: drug coated balloon

Optilume™ BPH Prostatic DCB Dilation Catheter

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Based on biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subject \> 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
• LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
• Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
• Post-void residual (PVR) ≤ 250 ml
• Prostate volume 20 - 80 gm as determined by TRUS
• Prostatic urethra length is 35 - 55 mm as determined by TRUS
• Able to complete the study protocol in the opinion of the investigator

You may not qualify if:

• Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
• Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
• Presence of a penile implant 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
• PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
• Confirmed or suspected malignancy of prostate or bladder
• Active or history of epididymitis within the past 3 months
• Previous pelvic irradiation or radical pelvic surgery
• Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
• Visible hematuria with subject urine sample without known contributing factor
• Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
• Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
• Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
• Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
• Use of 5-alpha reductase inhibitor within 6 months prior to treatment

Sponsors & Collaborators

• Urotronic Inc.: lead

Study Sites (5)

Union Medica Hospital

Santiago de los Caballeros, Santiago Province, Dominican Republic

Location

Urolaser SRL

Santo Domingo Oeste, Santo Domingo Province, Dominican Republic

Location

Centro Medico Dr. Canela, SRL

La Romana, Dominican Republic

Location

Consultorios Royal Center

Panama City, Urbanización Marbella Ciudad de Panamá, Panama

Location

Centro Especializado San Fernando

Panama City, Panama

Location

Related Publications (1)

• Pichardo M, Rijo E, Espino G, Lay RR, Estrella R, Gonzalez C, Fernandez M, Soriano D, Peralta IM, Kaplan SA. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023 Aug;41(8):2209-2215. doi: 10.1007/s00345-023-04473-1. Epub 2023 Jun 24.

  PMID: 37354260 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Interim review of safety data lead to refinement of device sizing and appropriate device size selection based on prostate dimensions for the final 30 subjects enrolled. Safety information reported for full cohort, as no pre-specified sub-analyses were planned.

Results Point of Contact

• Title: Sr. Clinical Project Manager
• Organization: Urotronic, Inc

jmoland@laborie.com

612-245-6434

Study Officials

• Jill Moland

  Urotronic Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: December 19, 2017
• Primary Completion: June 4, 2019
• Study Completion: May 25, 2024
• Last Updated: November 26, 2025
• Results First Posted: July 3, 2023

Record last verified: 2025-11

Locations

PA (2); DO (3)