Nevin Manimala Statistics

From consensus to validation: a multicenter study for design and development of a Holmium Laser Enucleation of the Prostate (HoLEP) hydrogel simulation platform

J Endourol. 2023 Nov 2. doi: 10.1089/end.2023.0430. Online ahead of print.


BACKGROUND: Holmium laser enucleation of the prostate (HoLEP) has emerged as a new gold standard for treatment of benign prostatic hyperplasia (BPH); 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 non-biohazardous 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 via a Delphi consensus over three rounds including 250 questions. Following consensus, a digital design was created and approved by experts, then used to fabricate a physical prototype using 3D printing and hydrogel molding. After a process of iterative prototype testing, experts completed a survey assessing the simulator with a five-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 85/250 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 procedure time (37.4 +/- 8.2 vs 16.7+/- 6.8 min), adenoma weight (79.6+/- 20.4 vs 36.2 +/- 9.9 gm), and complications (6 vs 22) respectively.

CONCLUSION: We have successfully completed a multi-center study to develop and validate a non-biohazardous benchtop simulator for HoLEP through modern education theory. A training curriculum including this simulator is currently under development.

PMID:37917099 | DOI:10.1089/end.2023.0430

By Nevin Manimala

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