NCT03653117

Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Hyperplasia, Benign

Interventions

Type	Name	Description
DEVICE	Transperineal laser ablation	Minimal invasive coagulation of prostatic tissue by laser

Timeline

• Start date: 2018-10-18
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2018-08-31
• Last updated: 2022-06-21

Locations

1 site across 1 country: Netherlands