Adaptive Pudendal Nerve Stimulation: A Pilot Study on Safety, Technical Feasibility, and Clinical Effect.

PURPOSE: To evaluate the safety, procedural feasibility, and pilot clinical outcomes for a new implanted device delivering adaptive pudendal nerve stimulation.

MATERIALS AND

METHODS

Thirteen adult women with treatment-refractory mixed (n = 8) or urge (n = 5) urinary incontinence were implanted with a Picostim-DyNeuMo system incorporating an implantable pulse generator and two quadripolar electrode leads. Leads were placed at the trunk and anterior part of the same pudendal nerve with radiological and electrophysiological guidance. Monophasic (pulse duration: 200 µs) stimulation at 15 Hz could be transiently adapted to 40 Hz by an embedded inertial detector (tapping over the device). Outcomes at 6 months included: safety (primary outcome), surgical feasibility, physiological (inc. urodynamic testing), and pilot clinical efficacy (voiding diaries; questionnaires).

RESULTS

Patients were implanted with two leads without technical difficulties. Reported adverse events (including one expected serious adverse device event) and device deficiencies were transient or resolved with intervention. Mean daily incontinence episodes decreased from 5.7 ± 2.8 at baseline to 1.8 ± 2.9 at 6 months. Eight patients were responders (> 50% improvement), with five regaining full continence by the final follow-up visit. All patients reported symptom improvement (PGI-I score) and clinically meaningful improvements in quality of life (ICIQ-OAB-QoL and ICIQ-UI-SF). Seventy percent of patients used the tap function to adapt therapy on a daily basis. Stimulation during awake urodynamics at 6 months showed significant increases in mean maximum cystometric capacity from baseline with basal stimulation and further increments during adaptive stimulation.

CONCLUSIONS

Pudendal nerve stimulation using the Picostim-DyNeuMo system is safe and technically feasible.

CLINICAL TRIAL REGISTRATION: NCT05241379.