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

Area of Science:

• Urology
• Biomedical Engineering
• Neuromodulation

Background:

• Urinary incontinence remains a significant challenge for many women.
• Existing treatments often have limitations or side effects.
• Novel neuromodulation approaches are being explored for improved efficacy.

Purpose of the Study:

• To assess the safety and feasibility of a new implanted device for adaptive pudendal nerve stimulation.
• To evaluate preliminary clinical outcomes in women with refractory urinary incontinence.
• To determine the procedural success and patient-reported benefits of the system.

Main Methods:

• A pilot study involving 13 women with mixed or urge urinary incontinence.
• Implantation of the Picostim-DyNeuMo system with leads placed on the pudendal nerve.
• Adaptive stimulation delivered at 15 Hz, adjustable to 40 Hz via a tap function.
• Evaluation of safety, feasibility, urodynamics, and patient-reported outcomes at 6 months.

Main Results:

• The implantation procedure was technically feasible with no major complications.
• Mean daily incontinence episodes decreased significantly from 5.7 to 1.8.
• Eight patients (62%) were responders, with five achieving full continence.
• Significant improvements in quality of life and bladder capacity were observed.

Conclusions:

• Pudendal nerve stimulation with the Picostim-DyNeuMo system is safe and technically feasible.
• The adaptive stimulation approach shows promising clinical efficacy for urinary incontinence.
• This technology offers a potential new therapeutic option for patients with refractory symptoms.