Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

NCT04760483 | Active Not Recruiting Phase 1 DMC FDA Device

• 1 other identifier: URN-20201001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Male Urogenital Diseases; Genital Diseases, Male; Prostatic Disease; Prostatic Hyperplasia

Keywords

BPH; Prostate Enlargement; Bladder Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• Feasibility and Tolerability of TPLA procedure

  Treatment tolerance and satisfaction will be assessed using a visual analog pain scale during the procedure

  30 minutes

Secondary Outcomes (4)

• 90 day Adverse Event profile of TPLA

  90 days

• Number of Participants with spontaneous voiding immediately following TPLA for BPH

  1 week

• Urinary Function following TPLA at the 3,6 & 12 months milestones

  12 months

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

  12 months

Other Outcomes (2)

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

  5 years

• Re-Treatment or Conversion to other surgical management

  5 years

Study Arms (1)

Transperineal Laser Ablation for BPH

EXPERIMENTAL

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.

Device: SoracteLite(TM) TPLA for BPH

Interventions

SoracteLite(TM) TPLA for BPH DEVICE

see prior section

Also known as: Laser ablation of prostate tissues

Transperineal Laser Ablation for BPH

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: Males with prostates
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of Lower Urinary Tract Symptoms (LUTS) measure by International Prostate Symptom Scores (IPSS) greater than 9
• Serum creatinine levels \<1.5 ng/dl and GFR \> 55
• Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry, pressure flow studies or urodynamic investigation
• Post-void residual (PVR): ≤ 250 mL
• Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
• Signed informed consent

You may not qualify if:

• Previous invasive prostate intervention (TURP, laser, ablation, etc.)
• History of prostate or bladder cancer
• Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
• Evidence of neurogenic bladder
• Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days
• Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
• Other conditions / status listed in full protocol

Sponsors & Collaborators

• Urological Research Network, LLC: lead

Study Sites (1)

Urology Specialist Group

Hialeah, Florida, 33016, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Male Urogenital Diseases; Genital Diseases, Male; Prostatic Diseases; Prostatic Hyperplasia; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urogenital Diseases; Genital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases

Study Officials

• Fernando Bianco, MD

  Urlogical Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study using intervention performed with Echolaser X4 that will be offered to men between 40 and 85 years of age, with moderate or severe international prostate symptoms scores and concomitant objective decrease in flow studies of at 30% consistent with bladder outlet obstruction

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 18, 2021
• Study Start: November 20, 2020
• Primary Completion: March 19, 2022
• Study Completion: March 20, 2026
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 4 months after complete enrollment

Locations

US (1)