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Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

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ClinicalTrials.gov Identifier: NCT03653117
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Elesta S.R.L.
Information provided by (Responsible Party):
Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia.

Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men.

Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia, Benign Device: Transperineal laser ablation Not Applicable

Detailed Description:

This study is set up as a prospective, single centre, interventional pilot study.

Eligible patients are diagnosed with LUTS due to BPO at the outpatient clinic of the department of Urology at the Academic Medical Center (AMC) and have an indication for surgical treatment. The investigators aim to include 20 patients.

Eligible patients will be informed about this study by the urologist in the outpatient clinic. Information about the study will be provided both orally and in written form.

The TPLA procedure is performed with the Echolaser X4 system. The system uses a diode laser source that operates at the 1064nm wavelength. The maximum energy delivered is 10 watts per laser source. The system works with the concept of thermoablation, resulting in coagulative necrosis of tissue. Two to four fibers are introduced in the prostate under untrasound vision. Ablation will be performed with 3 watts power per fibre and a total of 1200 - 1800 J will be delivered per fibre in 400 - 600 s.

Follow-up will exist of four visits following surgery at 4 weeks, three, six and 12 months. The visits imply medical history, adverse event registration, physical examination (on indication) and uroflowmetry. Patient-reported outcome measures (PROMs) are used to measure functional outcomes. Used PROMs are the International Prostate Symptom Score (IPSS), International Index of Erectile Function 15 (IIEF-15), Visual Analogue Scale (VAS) and hematuria grading scale (HGS). In addition to this, imaging will exist of a contrast enhanced ultrasound (CEUS) at four weeks and 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a prospective, single centre, interventional pilot study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: TPLA
TPLA procedure
Device: Transperineal laser ablation
Minimal invasive coagulation of prostatic tissue by laser
Other Name: Echolaser X4




Primary Outcome Measures :
  1. Incidence of technical successful TPLA treatments [ Time Frame: 24 hours following TPLA treatment ]
    Number of technical successful performed TPLA treatments without failures related to the machine or procedure.

  2. Incidence of TPLA treatment-emergent adverse events [ Time Frame: 30 days following TPLA treatment ]
    Number of adverse events using the CTCAE v5.0. Procedural safety is shown when there are no adverse events of grade 3 or higher.


Secondary Outcome Measures :
  1. Functional outcomes of TPLA [ Time Frame: 12 months following TPLA treatment ]
    Functional outcomes of TPLA measured by uroflowmetry, expressed in change of Qmax.

  2. Spontaneous voiding post TPLA [ Time Frame: 24 hours following TPLA treatment ]
    The presence of spontaneous voiding following TPLA treatment

  3. Erectile function [ Time Frame: 12 months following TPLA treatment ]
    To evaluate erectile function after TPLA treatment, measured by the International Index of Erectile function 15 (IIEF-15) IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; Erectile function: Q1-5 Score range 0-5 + Q15 score range 1-5, total score 1-30, higher indicates better outcome; Orgasmic function: Q9-10 Score range 0-5, total score 0-10, higher indicates better outcome; Sexual desire: Q11-12 Score range 1-5, total score 2-10, higher indicates better outcome; Intercourse satisfaction: Q6-8 Score range 0-5, total score 0-15, higher indicates better outcome; Overall satisfaction: Q13-14 Score range 1-5, total score 2-10, higher indicates better outcome; All subscale are summed to combine them to a total IIEF-15 score.

  4. Antegrade ejaculation [ Time Frame: 12 months following TPLA treatment ]
    To evaluate antegrade ejaculation after TPLA treatment, measured by patient reporting.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • ≥ 40 years of age
  • Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry or urodynamic investigation
  • Post-void residual (PVR): ≤ 250 mL
  • Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
  • Urodynamic investigation proven bladder outlet obstruction
  • Signed informed consent

Exclusion Criteria:

  • Previous invasive prostate intervention (TURP, laser, ablation, etc.)
  • History of prostate or bladder cancer
  • Indwelling Foley catheter or clean intermittent catheterization (CIC)
  • PSA of ≥ 3.0 ng/mL without negative biopsies
  • Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
  • Other conditions / status

    • Active urinary tract infection / prostatitis
    • Macroscopic haematuria without a known contributing factor
    • Poor detrusor muscle function or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries, (diabetic) polyneuropathy)
    • Concurrent malignancy except basal skin cancer
    • History of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
    • History of pelvic radiation therapy or radical pelvic surgery
    • History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
    • Bladder stones
    • Medical contraindication for undergoing TPLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)
    • Diagnosed or suspected bleeding disorder

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): NCT03653117


Contacts
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Contact: H Beerlage, Prof. +31 20 5664776 h.p.beerlage@amc.uva.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: T de Reijke, dr.       t.m.dereyke@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Elesta S.R.L.

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Responsible Party: Prof.dr. H.P. Beerlage, Chairman of the Urology department, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03653117     History of Changes
Other Study ID Numbers: 2018_149
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Transperineal laser ablation
LUTS
BPO
Laser ablation

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male