V02-01 design and validation of a non-biohazardous simulation model for holmium laser enucleation of the prostate (holep)

Introduction and Objective: HoLEP is a an underutilized, minimally invasive approach for the management of benign prostatic hyperplasia. Its steep learning curve and lack of realistic simulation platforms with incorporated objective metrics has hindered the adoption of this technique. A recent systemic review of the endoscopic enucleation of the prostate defined a steep learning curve impacting surgical and intraoperative metrics [1]. Few studies have also demonstrated a significant impact of this steep learning curve on patient-reported outcomes and complications [2,3]. Our aim is to demonstrate the design and validation of a high-fidelity non-biohazardous hydrogel platform fabricated to specifications attained through expert consensus. Methods: Validation was completed in 3 phases: Phase 1, Delphi methodology to gain consensus from an expert panel of endourologists. Consensus (>80% agreement) over 3 rounds defined 81 essential elements. Phase 2, Prototype development: these essential items were incorporated into prototypes fabricated using a combination of hydrogel molding and 3D printing. Phase 3: Validation comparing 6 experts (>100 HoLEP cases) and 6 novices (<5 HoLEP cases) performance from 4 centers using the consensus based objective and subjective metrics. During the validation phase, both experts and novices operated on anatomically identical HoLEP models with 120-gram prostates and used a Moses 2.0 HO:YAG laser with 2J and 40 Hz settings. Results: The model contained all 9 anatomic components (ex. bladder, ureteric orifices, lateral and median lobes, capsule, urethra), 7 objective evaluation metrics (ex. injury of ureteric orifices or bladder neck, perforation of the bladder or prostate capsule), and 5 procedural steps except for hemostasis and morcellation. Categorically overall utility, anatomical and procedural components, tissue fidelity, and assessment of performance received an 82%, 78%, 73% and 82% satisfaction score by experts respectively. Laser and instrument tissue interactions achieved highest (>85%) satisfaction. Experts outperformed novices in enucleation time (15.1 vs 47.5 min p=0.001), weight of adenoma resected (75.5 vs 49 g p=0.04) and developed global evaluation too (27 vs 15.8 p=0.001). All experts agreed the model could provide a safe training alternative, be used to evaluate trainee performance, and trial new approaches in a risk-free environment. Conclusions: This is the first consensus-based approach to design and provide initial validation of a non-biohazardous HoLEP simulation with incorporated evaluation metrics capable of supplementing HoLEP training. The model has the ability to create high-fidelity tissue textures which provides realistic tactile feedback, tissue planes and laser-tissue interactions which is not replicated in virtual reality simulations, thereby further bolstering its realism and use as a training model. Further validation studies are required to establish its effectiveness as a training platform. Sources: Enikeev, D., Morozov, A., Taratkin, M., Misrai, V., Rijo, E., Podoinitsin, A., ... & Herrmann, T. R. (2021). Systematic review of the endoscopic enucleation of the prostate learning curve. World Journal of Urology, 39(7), 2427-2438.3. 1. Shah, H. N., Sodha, H. S., Kharodawala, S. J., Khandkar, A. A., Hegde, S. S., & Bansal, M. B. (2008). Influence of prostate size on the outcome of holmium laser enucleation of the prostate. BJU international, 101(12), 1536-1541.2. Peyronnet, B., Robert, G., Comat, V., Rouprêt, M., Gomez-Sancha, F., Cornu, J. N., & Misrai, V. (2017). Learning curves and perioperative outcomes after endoscopic enucleation of the prostate: a comparison between GreenLight 532-nm and holmium lasers. World Journal of Urology, 35(6), 973-983.