Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

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    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 1 February 2021


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.


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.

Condition Benign prostatic hypertrophy, Benign Prostatic Hyperplasia (Enlarged Prostate), Benign Prostatic Hyperplasia (Enlarged Prostate)
Treatment Transperineal laser ablation
Clinical Study IdentifierNCT03653117
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on1 February 2021


Yes No Not Sure

Inclusion Criteria

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
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