Benchmarking TENSmini for Neuromodulation via Tibial Nerve Stimulation

Area of Science:

• Biomedical Engineering
• Urology
• Neuroscience

Background:

• Overactive bladder syndrome (OAB) significantly impacts patient quality of life.
• Transcutaneous tibial nerve stimulation (TTNS) is a noninvasive OAB treatment, but current devices have limitations.
• Existing TTNS devices are bulky, use adhesive electrodes, and may require professional setup, affecting adherence.

Purpose of the Study:

• To evaluate the short-term feasibility and therapeutic efficacy of a novel compact wearable electrical stimulator (TENSmini) for OAB.
• To benchmark the TENSmini against a clinically-approved device (DS7A) for bladder function modulation.
• To assess the potential of TENSmini as a viable alternative for OAB management.

Main Methods:

• A benchmarking study involving 47 healthy participants.
• Participants were pseudo-randomly assigned to three groups: TENSmini, clinical-grade DS7A, or Sham TTNS.
• Bladder micturition reflexes were monitored to assess the inhibitory effects of TTNS.

Main Results:

• The TENSmini device demonstrated inhibitory effects on bladder micturition reflexes comparable to the clinical-grade DS7A.
• Both active TTNS groups (TENSmini and DS7A) showed significant differences compared to the Sham (placebo) group.
• The study confirmed the safety of the TENSmini device in laboratory tests.

Conclusions:

• The TENSmini, a compact wearable TTNS device, shows potential as a feasible and effective alternative for OAB management.
• Its performance in modulating bladder reflexes is comparable to existing clinical devices.
• Future research should focus on long-term efficacy, usability, and patient adherence in clinical trials.