Holmium Laser Enucleation of the Prostate (HoLEP) is a minimally invasive surgical procedure for treating symptomatic benign prostatic hyperplasia (BPH) regardless of prostate size. Despite its advantages, HoLEP is recognized for having a steep learning curve. The development of a surgical robot to assist in this surgery could allow HoLEP to become more widely available by helping urologists overcome the learning curve through surgical navigation, spatial orientation and landmark recognition. This trial aims to demonstrate the safety and performance of the HoLEP procedure using the Beacon Platform. We report the data of first-in-human cases of RoLEP.
This prospective multicenter single-arm open-label pilot study assessed the intraoperative and postoperative outcomes of HoLEP using the Beacon Platform, a novel robotic single-arm system controlled through a tactile screen interphase. This innovative robot helps in the technical and ergonomic challenges of HoLEP by assisting in the prevention of injuries to critical structures such as the external sphincter, bladder neck and the capsule. At the beginning, the external sphincter and bladder neck were tagged to enhance navigation. Throughout the surgery, force applied to the capsule and the external sphincter was continuously monitored as a safety measure. The study involves two cohorts, roll-in (A) and intent-to-treat (B). Eligible participants were males with moderate to severe lower urinary tract symptoms (LUTS) and/or urinary retention due to BPH with prostate size ranging from 40-120 cc. The ASTRA trial protocol (NCT06668142) was approved at each investigational site by the Institutional Board Review. All the subjects were invited to participate, and informed consent was obtained. The primary safety endpoint was the incidence of a Clavien-Dindo grade 3a or higher complications within 30 days post-treatment. The primary performance endpoint was the successful competition of enucleation and morcellation without conversion to conventional HoLEP or another procedure.
To date 15 patients have been enrolled with an average prostate size of 55 cc. The mean enucleation and morcellation time were 112 and 11 minutes respectively. There were no intraoperative complications. Average hospital stay was 2 days, no re-operations nor transfusions were recorded. At 30 days, 1 patient reported urinary incontinence.
This proof-of-concept study demonstrates that robotic-assisted HoLEP using the Beacon Platform is a safe and feasible procedure. The introduction of robotic assistance in HoLEP has the potential to improve procedural standardization, facilitate tele-assistance, and support tele-mentoring in HoLEP training. Further studies with larger cohorts are required to validate these findings and assess the clinical impact of robotic assistance in HoLEP.
