Home-based transcutaneous tibial nerve stimulation for overactive bladder syndrome: a randomized, controlled study

Area of Science:

• Urology
• Neuromodulation
• Medical Devices

Background:

• Overactive bladder syndrome (OAB) significantly impacts quality of life.
• Urge urinary incontinence (UUI) is a common symptom associated with OAB.
• Non-invasive treatment options for OAB are continuously being explored.

Purpose of the Study:

• To evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for OAB treatment.
• To compare a novel home-based TPTNS device (ZIDA) against a sham procedure.
• To assess the impact of TPTNS on quality of life (QOL) in OAB patients.

Main Methods:

• A prospective, blinded, randomized, controlled trial was conducted with 40 OAB patients.
• Patients used either the active ZIDA device or a sham device weekly for 12 weeks at home.
• Outcomes were measured using bladder diaries and QOL surveys, with success defined by reduction in urgency voids/incontinence or frequency.

Main Results:

• The ZIDA group showed a significantly higher success rate (80%) compared to the sham control group (39%) (p=0.02).
• A significant improvement in QOL was observed in the ZIDA group compared to the sham group (mean difference -12.7).
• No significant adverse effects were reported for the TPTNS treatment.

Conclusions:

• TPTNS utilizing the ZIDA home-based stimulation device is a safe and effective treatment for OAB syndrome.
• The ZIDA device demonstrates a significant positive impact on the quality of life for patients with OAB.
• This non-invasive neuromodulation approach offers a promising therapeutic option for managing OAB symptoms.