Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder

Objective To evaluate the efficacy and safety of a wearable, smartphone‐controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB). Patients and Methods This multicentre, prospective, single‐blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA‐SI‐QoL) at baseline and after 4 weeks of treatment. Device‐related adverse events (AEs) were also evaluated. Results In the full analysis set (FAS), the mean ( sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were −3.5 (2.9) and −0.6 (2.4), respectively ( P < 0.01). Similar results were obtained in the per‐protocol set (PPS): −3.5 (2.9) vs −0.4 (2.3) ( P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks ( P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS ( P = 0.05), while it was significant in the PPS ( P = 0.02). In the FAS and PPS, AUA‐SI‐QoL significantly improved at 4 weeks in the two groups ( P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device‐related serious AEs were reported. Conclusions The non‐invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home‐based treatment modality. Future studies are warranted to confirm its longer‐term efficacy.