Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04760483
Recruitment Status : Active, not recruiting
First Posted : February 18, 2021
Last Update Posted : January 26, 2023
Information provided by (Responsible Party):
Urological Research Network, LLC

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

Condition or disease Intervention/treatment Phase
Male Urogenital Diseases Genital Diseases, Male Prostatic Disease Prostatic Hyperplasia Device: SoracteLite(TM) TPLA for BPH Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soractelite(Tm) Transperineal Laser Ablation for Benign Prostatic Hyperplasia With Bladder Outlet Obstruction
Actual Study Start Date : November 20, 2020
Actual Primary Completion Date : March 19, 2022
Estimated Study Completion Date : March 20, 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Transperineal Laser Ablation for BPH

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
see prior section
Other Name: Laser ablation of prostate tissues

Primary Outcome Measures :
  1. Feasibility and Tolerability of TPLA procedure [ Time Frame: 30 minutes ]
    Treatment tolerance and satisfaction will be assessed using a visual analog pain scale during the procedure

Secondary Outcome Measures :
  1. 90 day Adverse Event profile of TPLA [ Time Frame: 90 days ]
    Careful note of Emergent Adverse Events as assessed by CTCAE V5. Assessment will be upon removal of indwelling catheter, at the 15 day, 30 day and 90 day mark from the TPLA procedure date

  2. Number of Participants with spontaneous voiding immediately following TPLA for BPH [ Time Frame: 1 week ]
    Trial of void before patient is discharged. If fails a repeat voiding trial would be conducted within next 48 hours and if there is failure at 1 week.

  3. Urinary Function following TPLA at the 3,6 & 12 months milestones [ Time Frame: 12 months ]
    We will use standard validated questionnaires such as the international prostate symptoms score scale (I-PSS) as well as objective measures such as: urinary flow (average and max) and post void residuals at the identified milestones

  4. Number of Participants having Erections and Ejaculation following TPLA at 3,6 & 12 months [ Time Frame: 12 months ]
    Using SHIM scale min 1 max 25. Ability to have and sustain erections without any help or with help with a PDE5 inhibitor. Presence or absence of ejalucation

Other Outcome Measures:
  1. Urinary Function and Sexual Function 2-3-4-5-years after procedure [ Time Frame: 5 years ]
    We will use standard validated questionnaires such as the international prostate symptoms score scale (I-PSS) and Sexual Function inventory for Men (SHIM) during yearly in-person visit or via virtual interviews

  2. Re-Treatment or Conversion to other surgical management [ Time Frame: 5 years ]
    Will longitudinally observe the incidence of re-treatment with a similar procedure or conversion to other procedures such as: transurethral resection or ablation of the prostate, laser enucleation, REZUM, Urolift, Robotic open Open prostatectomy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with prostates
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04760483

Layout table for location information
United States, Florida
Urology Specialist Group
Hialeah, Florida, United States, 33016
Sponsors and Collaborators
Urological Research Network, LLC
Layout table for investigator information
Principal Investigator: Fernando Bianco, MD Urlogical Research Network
Additional Information:
Layout table for additonal information
Responsible Party: Urological Research Network, LLC Identifier: NCT04760483    
Other Study ID Numbers: URN-20201001
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Initial analysis after all subjects complete 3 month evaluation
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 4 months after complete enrollment

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Urological Research Network, LLC:
Prostate Enlargement
Bladder Outlet Obstruction
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Genital Diseases
Prostatic Diseases
Urogenital Diseases
Genital Diseases, Male
Male Urogenital Diseases
Pathologic Processes