Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction
Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction
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.
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