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Laser Ablation

Laser Ablation for Benign Prostatic Hyperplasia

Phase 1

Waitlist Available

Led By Fernando Bianco, MD

Research Sponsored by Urological Research Network, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound

Presence of Lower Urinary Tract Symptoms (LUTS) measure by International Prostate Symptom Scores (IPSS) greater than 9

Must not have

Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury

History of prostate or bladder cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will help assess if transperineal laser ablation of the prostate is a safe and effective treatment for benign prostatic hypertrophy.

Who is the study for?

Men aged 40-85 with benign prostatic hyperplasia (BPH) can join this trial. They must have certain urinary flow rates, a prostate size within specific limits, and moderate to severe lower urinary tract symptoms but no history of invasive prostate interventions or major neurological conditions. Participants need normal kidney function and the ability to stop blood thinners temporarily.

What is being tested?

The study is testing SoracteLite(TM) TPLA for BPH in an office setting under local anesthesia. It aims to improve quality of life by reducing risks associated with traditional surgical treatments for BPH while preserving sexual functions like ejaculation.

What are the potential side effects?

Possible side effects include discomfort at the treatment site, temporary difficulty urinating, blood in urine, changes in sexual function including erectile dysfunction or altered ejaculation, and potential impacts on bladder control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate size is between 30 and 120 cc.

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I have moderate to severe urinary symptoms.

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My kidney function is normal, with creatinine levels below 1.5 ng/dl and GFR above 55.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major neurological conditions like Alzheimer's or Parkinson's.

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I have had prostate or bladder cancer in the past.

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I have had surgery or other treatments for prostate issues.

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I have bladder control issues due to nerve problems.

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I cannot or will not stop my blood thinner medication temporarily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility and Tolerability of TPLA procedure

Secondary study objectives

90 day Adverse Event profile of TPLA

Number of Participants having Erections and Ejaculation following TPLA at 3,6 & 12 months

Number of Participants with spontaneous voiding immediately following TPLA for BPH

+1 more

Other study objectives

Re-Treatment or Conversion to other surgical management

Urinary Function and Sexual Function 2-3-4-5-years after procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transperineal Laser Ablation for BPHExperimental Treatment1 Intervention

Ceftriaxone 250 mg IM as antibiotic prophylaxis. Local Anesthesia: perineal skin will be infiltrated with 10 cc of Lidocaine 2% and then each neurovascular bundle will be infiltrated with 5 - 10 cc. Nitrous self-administered anesthesia will be available. One or two laser fibers from Echolaser x4 will be placed in each of the two prostate lobes using the plan. Treatment will be executed following Echolaser smart Interface planning, needles will follow targeted location using stepper grid under a transperineal approach in a sagittal plane. Ablation with 5 watts power per fiber, a total of \~ 1800 J will be delivered. We will evaluate pain measures and procedure tolerance using visual analog pain scale Upon completion we will measure coagulation zone with TRUS. Before discharge, trial of void will be conducted. Patients with a residual greater than 200 cc will have an indwelling catheter placed and will be discharged with it.

0 / 8Eligibility criteria met