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Optilume™ BPH Catheter System for Enlarged Prostate (PINNACLE Trial)

Waitlist Available
Led By Steven A Kaplan, MD
Research Sponsored by Urotronic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
Male subject 50-80 years of age who has symptomatic BPH
Must not have
Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
Visible or invisible hematuria (> 4 Red Blood Cells (RBCs) per high power field) on 2 separate urine specimens within the last 3 months without a known contributing factor
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights


This trial is testing a new device to treat BPH and establish if it is safe and effective.

Who is the study for?
Men aged 50-80 with symptomatic BPH, having a prostate size of 20 to 80 gm and specific urinary flow rates. They must have had an inadequate response or contraindication to BPH medical therapy. Exclusions include those with certain prostate conditions, recent use of specific drugs, history of hypersensitivity reactions to paclitaxel, confirmed malignancies, uncontrolled diabetes, and more.Check my eligibility
What is being tested?
The PINNACLE trial is testing the Optilume™ BPH Catheter System against a sham device in men with benign prostatic hyperplasia (BPH). It's designed to see if this system is safe and effective for treating symptoms associated with an enlarged prostate.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort or pain at the catheter insertion site, urinary tract infections (UTI), bleeding or irritation within the urethra or bladder due to device usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My prostate urethra length is between 32 mm and 55 mm.
I am a man aged 50-80 with symptoms of an enlarged prostate.
My urine flow rate is between 5 and 12 ml/sec.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have not used 5-alpha reductase inhibitors like Avodart in the last 6 months.
I have had blood in my urine twice in the last 3 months without a clear reason.
My bladder muscle is weak.
My prostate has a significant growth into my bladder.
I have had radiation or surgery for a pelvic injury.
I have an artificial device in my urinary system.
I have had a bacterial infection in my prostate in the last year.
I agree to use protection or abstain from sex for 30 days after treatment.
I have had rectal surgery, but not for hemorrhoids.
I have not had sudden inability to urinate in the last 6 months.
I have had issues with my bladder or urethra, like strictures or spasms.
I currently have a UTI confirmed by a lab test.
I haven't taken any blood-thinning medications like aspirin in the last 10 days.
I have or might have prostate or bladder cancer.
I have a condition affecting my bladder or its control due to nerve issues.
I cannot avoid sex or use effective birth control for 6 months after the procedure.
I can communicate clearly and complete questionnaires without any cognitive issues.
I have a history of not being able to control my urination.
I have had a procedure or surgery on my prostate.
My PSA level is 10 ng/ml or higher, but prostate cancer has been ruled out.
I have stones in my bladder or prostatic urethra.
My diabetes is not under control (A1c is 8% or higher).


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in International Prostate Symptom Score (IPSS)
Major Device Related Serious Complications

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pharmacokinetics Optilume ArmExperimental Treatment1 Intervention
A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System
Group II: Optilume™ BPH Catheter SystemExperimental Treatment1 Intervention
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Group III: Sham DevicePlacebo Group1 Intervention
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Optilume™ BPH Catheter System treats an enlarged prostate by mechanically dilating the prostatic urethra, which relieves obstruction and improves urine flow. This system combines dilation with drug-coated balloon technology to maintain urethral patency. Other common treatments include alpha-blockers, which relax the smooth muscles of the prostate and bladder neck, and 5-alpha-reductase inhibitors, which shrink the prostate by inhibiting hormone-induced growth. Minimally invasive surgical options, like transurethral resection of the prostate (TURP), remove excess prostate tissue. Understanding these mechanisms helps patients and doctors choose the most suitable treatment based on individual needs and health conditions.
Minimally invasive surgical therapies for benign prostatic hypertrophy: The rise in minimally invasive surgical therapies.The influence of the medical treatment of LUTS on benign prostatic hyperplasia surgery: do we operate too late?

Find a Location

Who is running the clinical trial?

Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
432 Total Patients Enrolled
ClinLogix. LLCIndustry Sponsor
10 Previous Clinical Trials
1,205 Total Patients Enrolled
Steven A Kaplan, MDPrincipal InvestigatorMount Sinai Health System

Media Library

Optilume BPH Catheter System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04131907 — N/A
Enlarged Prostate Research Study Groups: Sham Device, Optilume™ BPH Catheter System, Pharmacokinetics Optilume Arm
Enlarged Prostate Clinical Trial 2023: Optilume BPH Catheter System Highlights & Side Effects. Trial Name: NCT04131907 — N/A
Optilume BPH Catheter System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04131907 — N/A
Enlarged Prostate Patient Testimony for trial: Trial Name: NCT04131907 — N/A
~92 spots leftby Jul 2025