What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate (BPH) include medications such as alpha blockers and 5-alpha reductase inhibitors, minimally invasive procedures like transurethral resection of the prostate (TURP), and mechanical dilation methods such as the Optilume™ BPH Catheter System. The side effects of these treatments can vary. Alpha blockers may cause dizziness, fatigue, and orthostatic hypotension. 5-alpha reductase inhibitors can lead to sexual dysfunction and decreased libido. TURP may result in bleeding, infection, and urinary incontinence. Mechanical dilation methods, including the Optilume™ BPH Catheter System, can cause urinary tract infections, post-procedural hematuria, and dysuria. Overall, while these treatments are effective, they come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for benign prostatic hyperplasia (BPH), including medications and surgical options. Medications such as alpha-adrenergic antagonists (e.g., alfuzosin, tamsulosin) and 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) are commonly used. Surgical treatments include transurethral resection of the prostate (TURP), laser therapies, and minimally invasive surgical therapies like transurethral microwave therapy and transurethral needle ablation. While specific FDA approvals for mechanical dilation of the prostatic urethra, similar to the Optilume™ BPH Catheter System, are not detailed, these broader categories encompass the range of available treatments for BPH.

What other types of research exist?

Promising alternatives to the Optilume™ BPH Catheter System for treating an enlarged prostate include: 1) Modified prostatic UroLume Wallstent, which has shown significant improvement in mean peak flow rates and residual urine volumes. 2) Medications like alfuzosin, which have been effective in increasing the success rate of trial without catheter (TWOC) and reducing the need for surgery. 3) Surgical options such as Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation, both of which have demonstrated efficacy and safety in randomized clinical trials.

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Device

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

N/A

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is testing a special catheter designed to treat men with an enlarged prostate. The device helps to open up the urinary passage, making it easier to urinate. The goal is to see if this treatment is safe and effective for these patients.

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.

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.

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

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My prostate urethra length is between 32 mm and 55 mm.

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I am a man aged 50-80 with symptoms of an enlarged prostate.

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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:

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I have not used 5-alpha reductase inhibitors like Avodart in the last 6 months.

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I have had blood in my urine twice in the last 3 months without a clear reason.

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My bladder muscle is weak.

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My prostate has a significant growth into my bladder.

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I have had radiation or surgery for a pelvic injury.

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I have an artificial device in my urinary system.

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I have had a bacterial infection in my prostate in the last year.

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I agree to use protection or abstain from sex for 30 days after treatment.

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I have had rectal surgery, but not for hemorrhoids.

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I have not had sudden inability to urinate in the last 6 months.

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I have had issues with my bladder or urethra, like strictures or spasms.

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I currently have a UTI confirmed by a lab test.

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I haven't taken any blood-thinning medications like aspirin in the last 10 days.

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I have or might have prostate or bladder cancer.

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I have a condition affecting my bladder or its control due to nerve issues.

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I cannot avoid sex or use effective birth control for 6 months after the procedure.

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I can communicate clearly and complete questionnaires without any cognitive issues.

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I have a history of not being able to control my urination.

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I have had a procedure or surgery on my prostate.

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My PSA level is 10 ng/ml or higher, but prostate cancer has been ruled out.

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I have stones in my bladder or prostatic urethra.

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My diabetes is not under control (A1c is 8% or higher).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 25Eligibility criteria met

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?