From Consensus to Validation: A Multicenter Study for Design and Development of a Holmium Laser Enucleation of the Prostate Hydrogel Simulation Platform

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.