This approach is distinguished by its fully non-invasive design and integration into everyday wear, eliminating the need for surgery or frequent clinical visits required by sacral or percutaneous tibial nerve stimulation. Its charge-balanced waveform minimizes tissue irritation, and customizable pulse parameters enhance patient comfort and treatment efficacy. By targeting foot afferents rather than pelvic or perianal nerves, it offers a discreet, easily maintained system that supports extended use, high compliance and broad applicability across urological, gastrointestinal and sexual health indications.
Description
Surface electrodes embedded in a wearable garment such as a sock deliver transcutaneous electrical pulses to specific regions of the foot—metatarsal, calcaneus, talus, cuboid, cuneiform or navicular—to stimulate somatic afferent nerves non-invasively. These electrodes connect to a portable pulse generator that emits charge-balanced, biphasic rectangular pulses (0.1–3 ms duration, 1–50 Hz frequency, 1–50 V or 0.5–2× toe-twitch threshold) in user-defined on/off intervals (0.5–200 s on). Clinical targets include inhibition of bladder contractions and suppression of overactive bladder and fecal incontinence, improvement of irritable bowel symptoms and relief of constipation, as well as modulation of sexual function. A secure, wireless external transmitter authenticated via encrypted signals enables remote control and prevents unintended stimulation.
Applications
Overactive bladder therapy
Fecal incontinence treatment
Irritable bowel syndrome relief
Constipation management
Erectile dysfunction aid
Advantages
Non-invasive neuromodulation avoiding surgery and implants
Portable, wearable system (e.g., sock integration) for home use
Effective treatment across multiple conditions: overactive bladder, urinary/fecal incontinence, IBS, constipation, and sexual dysfunction
Enhanced patient comfort and compliance with extended electrode wear
Reduces clinical visits through self-administered therapy
Secure wireless control to prevent unintended stimulation
IP Status
https://patents.google.com/patent/US11191958B2
