Clinical trial NCT03653117: Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction
Official title: Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia, Benign
Keywords: Transperineal laser ablation
LUTS
BPO
Laser ablation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Elesta S.R.L.
First posted: 2018-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, single centre, interventional pilot study.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of technical successful TPLA treatments
timeFrame: 24 hours following TPLA treatment
measure: Incidence of TPLA treatment-emergent adverse events
timeFrame: 30 days following TPLA treatment
Secondary outcomes:
measure: Functional outcomes of TPLA
timeFrame: 12 months following TPLA treatment
measure: Spontaneous voiding post TPLA
timeFrame: 24 hours following TPLA treatment
measure: Erectile function
timeFrame: 12 months following TPLA treatment
measure: Antegrade ejaculation
timeFrame: 12 months following TPLA treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
References: