Percutaneous tibial nerve stimulation (PTNS) is an established therapy for patients with non-neurogenic overactive bladder (NNOAB). However, it imposes a significant logistical burden due to the requirement for repeated in-clinic treatments. We hypothesize that patients could achieve comparable therapeutic outcomes through at-home administration using a wearable microneedle-based PTNS system.

A multicenter, prospective, randomized, sham-controlled, single-blind study (3:1 randomization) was conducted with patients diagnosed with NNOAB. This analysis presents interim results from 18 patients who has completed this pilot study of 12 weeks of treatment.
Therapy consisted of twelve weekly 30-minute stimulation sessions, self-administered at home, following a single in-clinic training visit. Treatment was delivered using a wearable percutaneous microneedle array stimulator (Confidanz® Smart Patch) over the nerve on the ankle. Patient-controlled biphasic stimulation (up to 30 mA at 20 Hz) was applied via a percutaneous microneedle array positioned using a guided system and mobile application. Patients were monitored through a cloud-based clinician portal with additional follow-up as needed.
The sham group followed an identical protocol without active current delivery. To minimize bias, patients in both sham and treatment arms were advised at the beginning of the study that efficacy may be independent of stimulation strength or sensations around the ankle. Outcomes were assessed using 3-day bladder diaries, the International Consultation on Incontinence Questionnaire (ICIQ), Overactive Bladder Symptom Score (OABSS), Patient Global Impression of Improvement (PGI-I), and other patient feedback surveys. Two-way ANOVA with Dunnet multiple comparison test was used for data analysis.

Patients in the treatment arm demonstrated a median reduction of 2.0 voids per day. The response rate (≥50% reduction in incontinence episodes) was 83%, with three patients achieving complete continence. Urgency scores improved significantly in the treatment group compared to sham at 12 weeks (Figure 1A). No serious device-related adverse events have been reported to date.
The treatment group showed progressive and statistically significant improvements in symptom scores at 12 weeks compared to baseline ( OABSS: −2.1 ± 2.5 ,  p<0.05  ;  ICIQ: −2.8 ± 0.4, p<0.01 ), whereas the sham group showed no significant changes (Figure 1B). There is statistical significant reduction in both OABSS and ICIQ scores observed in the treatment group, in the absence of change in the sham group, supports the efficacy of the intervention in reducing symptom severity.

Patient-reported outcomes indicated high usability and satisfaction: 88% preferred the device over medication. Patients reported: ease of use 4.5/5, device comfort 4.2/5, and willingness to recommend to other OAB 4.2/5.

These findings demonstrate that patients can safely and effectively self-administer PTNS at home using a wearable microneedle array system. Clinically meaningful improvements in urinary symptoms were observed in this pilot study, with both early and sustained benefit over the treatment period. The ability to perform therapy at home represents a significant advantage in terms of convenience and patient adherence.

This study supports a paradigm shift in the safe delivery of PTNS from clinic-based to at-home therapy. Patient-reported outcomes indicated high usability and satisfaction. This approach has the potential to improve accessibility, reduce treatment burden, and enhance long-term adherence.