Initial Evaluation of a Novel Modulated Radiofrequency-based Bladder Denervation Device.

Journal Article (Journal Article)

OBJECTIVE: To determine if targeted and modulated radiofrequency ablation (RFA) of the urinary bladder using our novel ablation device (Denerblate) reduces bladder nerve density, potentially leading to a novel strategy for the management of overactive bladder. METHODS: Fifteen pigs were divided into 4 groups: control (n = 3), 1-week (n = 4), 4-week (n = 4) and 12-week (n = 4) survival times. Denerblate was deployed on the trigone area of the bladder. Three 240-second cycles of modulated RFA were applied with 30 seconds between cycles. At the end of each survival term, urinary bladders were harvested for histopathologic evaluation. Nerve count and density were manually calculated. RESULTS: All procedures were successfully completed, and all animals survived to the desired time points. Mean nerve density (nerves/mm2) was highest in the control and 1-week survival group compared to the 4-week and 12-week groups, both of which demonstrated significant diminishment. Nerve density in the bladder neck at control, 1 week, 4 weeks, and 12 weeks were 1.8, 1.35, 0.87, and 0.12, respectively (P <.001). Nerve density in the bladder trigone area at control, 1 week, 4 weeks, and 12 weeks were 1.5, 0.98, 0.65, and 0.112, respectively (P <.001). Epithelial heat injury was observed in 14.3% at 1 week, 10.7% at 4 weeks, but completely resolved by 12 weeks. CONCLUSION: In the porcine model, modulated RFA delivered by our novel device reduced nerve density in the bladder neck and trigone by 88.6% and 88.9% at 12 weeks without evidence of lasting epithelial injury.

Full Text

Duke Authors

Cited Authors

  • Okhunov, Z; Mao, R; Jefferson, FA; Yoon, R; Patel, RM; Lee, TK; Huang, J; Zhang, Y; Ghoniem, GG; Li, GP; Landman, J

Published Date

  • December 2019

Published In

Volume / Issue

  • 134 /

Start / End Page

  • 237 - 242

PubMed ID

  • 31539508

Electronic International Standard Serial Number (EISSN)

  • 1527-9995

Digital Object Identifier (DOI)

  • 10.1016/j.urology.2019.08.046


  • eng

Conference Location

  • United States