Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 30, 2019
Open Peer Review Period: Aug 2, 2019 - Sep 27, 2019
(currently open for review)
Transperineal Laser Ablation treatment for LUTS due to Benign Prostatic Obstruction: a prospective in vivo pilot study protocol
Standard surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) all use a transurethral approach. Drawbacks are the need for general or spinal anaesthesia, and complications such as haematuria, strictures and cloth retention. Therefore, a minimal invasive technique under local anaesthesia is desired to improve patient safety. Recently, SoracteLiteTM transperineal laser ablation (TPLA) has been introduced as a novel minimal invasive treatment for BPO. The system used is unique because four laser sources are independently available. This 1064nm diode laser induces coagulative necrosis. Moreover, TPLA is unique because it has a transperineal approach and can be performed under local anaesthesia in an outpatient setting.
The primary objective of this study is to determine safety and feasibility of TPLA treatment for men with LUTS due to BPO and fit for standard surgery. The secondary objectives are to determine functional outcomes by flowmetry and patient reported outcome measures, side effects, and tissue changes observed on imaging.
This study is a prospective, single centre, interventional pilot study, IDEAL stage 2a and will include 20 patients. Eligible patients are men ≥40 years of age, with a prostate volume of 30 – 120 cc, urodynamically proven bladder outlet obstruction and a peak urinary flow of 5 – 15 mL/sec. All patients undergo transperineal laser ablation of their prostate under local anaesthesia using the EchoLaser system. Depending on the prostate volume, two to four laser fibres are placed bilaterally into the prostate. Patient follow-up consists of uroflowmetry, patient-reported outcome measures and imaging by contrast-enhanced ultrasound. Total follow-up is 12 months following treatment.
Presently, recruitment of patients is ongoing. Publication of first results is expected by early 2020.
Transperineal laser ablation offers the potential to be a novel minimal invasive technique for treatment of LUTS due to BPO in men fit for standard desobstruction. This study will evaluate the safety and feasibility of TPLA and report on functional outcomes and tissue changes observed on imaging following TPLA treatment. Clinical Trial: Clinical trials: TPLA for BPO; NCT03653117; https://clinicaltrials.gov/ct2/show/NCT03653117 This trial is registered in the Dutch Toetsingonline trial registration system, number: NL66057.018.18 (https://www.toetsingonline.nl/)
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