Trial Summary
What is the purpose of this trial?This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH).
BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy
The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements
Eligibility Criteria
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.Inclusion Criteria
Post-void residual (PVR): ≤ 250 mL
My prostate size is between 30 and 120 cc.
I have moderate to severe urinary symptoms.
+3 more
Exclusion Criteria
Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days
I do not have major neurological conditions like Alzheimer's or Parkinson's.
I have had prostate or bladder cancer in the past.
+4 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Urology Specialist GroupHialeah, FL
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Who Is Running the Clinical Trial?
Urological Research Network, LLCLead Sponsor