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Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

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ClinicalTrials.gov Identifier: NCT04760483
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : November 20, 2022

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. TREATMENT FEASBILITY IN OFFICE SETTING OF TPLA FOR BPH [ Time Frame: Under 30 minutes ]
    Completion of treatment intent, will evaluate if any procedure ought to be aborted, will measure pain using a visual analog scales. Watts scalation during treatment will be tested


Secondary Outcome Measures :
  1. EFFICACY OF TPLA FOR BPH [ Time Frame: 4 weeks and up to 1 year ]
    Efficacy is measured by improvement in subjective (ie- IPSS min 1 max 35) and objective (ie flow studies) outcome measures. Patient reported outcomes

  2. Hematuria, Hematospermia [ Time Frame: 1 day and up to 1 year post intervention ]
    Presence, absence and duration

  3. SPONTANEUS VOIDING FOLLOWING TPLA FOR BPH [ Time Frame: Up to 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.

  4. Erections and Ejaculation [ Time Frame: 4 weeks and up to 1 year ]
    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

  5. SAFETY PROFILE OF TPLA FOR BPH [ Time Frame: Up to 4 weeks ]
    Safety is assessed by device and procedural adverse events using the CTCAE v5.0 within the first 30 days. SoracteLite(TM) TPLA is safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04760483


Contacts
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Contact: Fernando J Bianco, MD 3056061761 drbianco@besturology.net
Contact: Cielo D Guerra 3056061761 cielo@besturology.net

Locations
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United States, Florida
Urology Specialist Group Recruiting
Hialeah, Florida, United States, 33016
Contact: Fernando J Bianco    305-606-1761    drbianco@besturology.net   
Contact: Cielo D Guerra    3056061761    cielo@besturology.net   
Sponsors and Collaborators
Urological Research Network, LLC
Additional Information:
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Responsible Party: Urological Research Network, LLC
ClinicalTrials.gov Identifier: NCT04760483    
Other Study ID Numbers: URN-20201001
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
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

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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:
BPH
Prostate Enlargement
Bladder Outlet Obstruction
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Prostatic Diseases
Hyperplasia
Pathologic Processes