From Consensus to Validation: A Multicenter Study for Design and Development of a Holmium Laser Enucleation of the Prostate Hydrogel Simulation Platform
Lauren Shepard, Nathan Schuler, Gopal Narang, Shaan Setia, Akhil Das, Nicole L. Miller, Mitchell R. Humphreys, Amy E. Krambeck, Ahmed Ghazi
Abstract
Background:Holmium laser enucleation of the prostate (HoLEP) has emerged as a new gold standard for treatment of benign prostatic hyperplasia; however, its steep learning curve hinders generalization of this technique. Therefore, there is a need for a benchtop HoLEP simulator to reduce this learning curve and provide training. We have developed a nonbiohazardous HoLEP simulator using modern education theory and validated it in a multicenter study. Materials and Methods:Six experts established key components for a HoLEP simulator through a Delphi consensus over three rounds including 250 questions. After consensus, a digital design was created and approved by experts, then used to fabricate a physical prototype using three-dimensional printing and hydrogel molding. After a process of iterative prototype testing, experts completed a survey assessing the simulator with a 5-point Likert scale for final approval. The approved model was validated with 56 expert and novice participants at seven institutions using subjective and objective performance metrics. Results:Consensus was reached on 85 of 250 questions, and experts found the physical model to adequately replicate 82.5% of required features. Objective metrics were statistically significant (p < 0.0001) when comparing experts and novices for enucleation time (37.4 ± 8.2 vs 16.7 ± 6.8 minutes), adenoma weight (79.6 ± 20.4 vs 36.2 ± 9.9 g), and complications (6 vs 22), respectively. Conclusion:We have effectively completed a multicenter study to develop and validate a nonbiohazardous benchtop simulator for HoLEP through modern education theory. A training curriculum including this simulator is currently under development.