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

PURPOSE: Transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of overactive bladder syndrome (OAB), with or without urge urinary incontinence (UUI) using electrodes imbedded in the fabric of a conventional sock and an attachable battery-operated stimulation device (ZIDA®-Exodus Innovations, Sufa, Israel), was compared for effectiveness and safety to a sham procedure in a prospective, blinded, randomized, controlled trial.

METHODS

Forty patients with diagnosed with OAB were recruited from a single site. There were two groups: a treatment group (21 patients, mean age 64), which used an active ZIDA® activation device (ZIDA) and a sham control group (SCG, 19 patients, mean age 72) randomized in a 1:1 ratio. After individual fitting of the sock and face-to-face instruction in the use of the device, patients in both groups self-administered the treatment once weekly for 30 min at home for a duration of 12 weeks. Prior to randomization and in Week 12, patients completed two 3-day bladder diaries and a quality-of-life (QOL) survey. Treatment success was defined as at least a 50% reduction in urgency voids with or without incontinence or at least a 30% reduction in 24-h frequency from baseline to Week 12. The key secondary endpoint was change in QOL from baseline to Week 12.

RESULTS

The success rate for the primary endpoint in the ZIDA group was 80% (n = 16/20) versus 39% (n = 7/18) in the SCG (p = 0.02). For QOL, the least squares mean difference in change from baseline to Week 12 between the ZIDA and sham control arms total score was - 12.7 (95% CI - 20.2 to - 5.1). No significant adverse effects were observed.

CONCLUSION

TPTNS using the ZIDA home-based stimulation device offers a safe and effective treatment for patients with OAB syndrome and improves QOL.

TRIAL REGESTRATION: TRN: NCT04470765.