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Benchmarking TENSmini for Neuromodulation via Tibial Nerve Stimulation.

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    IEEE Transactions on Neural Systems and Rehabilitation Engineering : a Publication of the IEEE Engineering in Medicine and Biology Society
    |May 29, 2025
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    Summary
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    A new wearable device for transcutaneous tibial nerve stimulation (TTNS) shows promise for treating overactive bladder (OAB). This compact stimulator demonstrated comparable efficacy to a clinical device in modulating bladder reflexes.

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    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.