Smart wearable TENS device for overactive bladder management

Abstract

Overactive bladder (OAB) syndrome is a chronic condition of global prevalence that greatly affects patient quality of life. While percutaneous tibial nerve stimulation (PTNS) is now a well-established treatment, its invasiveness limits its usability. Recent advances in transcutaneous tibial nerve stimulation (TTNS) treatments have shown great promise, but most commercially available neuro-stimulator are relatively large, reliant on adhesive gel electrodes and require professional help. This makes them particularly difficult to use by older home-bound patients with sensitive/fragile skin, who are often the target demographic. These limitations reduce patient adherence and consistency in treatment. To address these issues, this thesis details the development of a compact, wearable device (TENSmini, weighing 31 g), specifically designed to be connected to a washable sock featuring conductive textile electrodes. This unobtrusive device allows users to control stimulation parameters wirelessly via mobile devices, enabling tailored TTNS treatments. Necessary features, including consistent electrode positioning, galvanic isolation and automated disconnection detection, were incorporated to ensure enhanced user protection. In two pilot studies involving 57 healthy participants, the TENSmini device effectively stimulated the tibial nerve (measured via electromyographic (EMG) recording) and demonstrated short-term inhibitory effects on bladder control, with performance comparable to a clinical-grade stimulator. While further clinical studies are needed to evaluate its long-term therapeutic effectiveness, the TENSmini offers patients enhanced safety, usability, and the potential for considerable improvements in adherence to home-based OAB management.