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

Area of Science:

• Urology
• Minimally Invasive Surgery
• Histopathology

Background:

• Overactive bladder (OAB) significantly impacts quality of life.
• Current OAB treatments have limitations.
• Reducing bladder nerve density is a potential therapeutic strategy.

Purpose of the Study:

• To evaluate the efficacy of modulated radiofrequency ablation (RFA) using the novel Denerblate device in reducing bladder nerve density.
• To assess the safety and potential of RFA as a novel management strategy for overactive bladder.

Main Methods:

• A porcine model was used with 15 animals divided into control and RFA treatment groups (1, 4, and 12-week survival).
• The Denerblate device delivered modulated RFA to the bladder trigone.
• Urinary bladders were harvested for histopathologic evaluation, including manual nerve count and density assessment.

Main Results:

• Radiofrequency ablation (RFA) significantly reduced nerve density in the bladder neck and trigone.
• Nerve density decreased by 88.6% in the bladder neck and 88.9% in the trigone at 12 weeks post-procedure (P <.001).
• Epithelial heat injury was transient and resolved by 12 weeks.

Conclusions:

• Modulated RFA with the Denerblate device effectively reduces bladder nerve density in a porcine model.
• This technique shows promise as a novel, minimally invasive strategy for managing overactive bladder.
• The procedure demonstrated a favorable safety profile with no lasting epithelial injury.