Safety and Efficacy of a Novel Direct Bladder Wall Stimulation Device in Canines
Anagha U. Kotkar, Zachariah J. Sperry, Carlos J. Anaya, Andrew S. Bohannon, Nicolette D. Jackson, Collin R. Johnson, Emily M. LaFrance, Stacey E. SeidlPurpose:
This preclinical study assessed safety and efficacy of direct bladder wall stimulation in canines to address the lack of chronic data supporting implantable therapies for underactive bladder related voiding dysfunctions.
Materials and Method:
Two leads terminating in surface electrodes were sutured to the posterior bladder wall trigone region and connected to a subcutaneous implantable pulse generator. Animals were split between those receiving daily active stimulation and sham stimulation for up to 24 weeks. Safety evaluations included clinical observations, hematology, serum chemistry, urinalysis, and macroscopic and microscopic tissue examinations. Efficacy was assessed by observed voiding behavior during and after stimulation.
Results:
Animals tolerated surgical implantation and chronic stimulation without major complications. Behavioral observations indicated no sustained pain or distress beyond expected postoperative recovery or effects of stimulation. Adverse events included incision dehiscence, seroma, and chronic infection, all associated with the pulse generator and managed with standard veterinary care. Clinical pathology and urinalysis values remained within normal physiological ranges. Low-grade inflammatory responses surrounding electrodes, lead tracts, and implantable pulse generator pockets were consistent with typical foreign-body reactions. Overall, chronic system use was well tolerated, with no evidence of systemic toxicity.
Conclusions:
Bladder voiding was commonly observed during active stimulation, confirming functional efficacy and safety. The stimulation group demonstrated significantly greater bladder voiding compared with the sham group (44.1 ± 2.6% vs 9.3 ± 3.0%). These findings support the safety and efficacy of this system and justify further investigation, including human clinical trials for underactive bladder and related voiding dysfunctions.