Transcutaneous posterior tibial nerve stimulation (TPTNS) has been proposed as a home-based, patient-centered therapy that could improve access to treatment. Aim of the study was to evaluate the safety and efficacy of 12 weeks of TPTNS in reducing urinary symptoms in patients with OAB in patients non-responder to previous conservative treatments.

This was a single- centre, prospective study which included patients of both sexes non-responder to pharmacological therapy for OAB. Baseline evaluation comprised 3- day bladder diary, uroflowmetry (UF) with post void residual volume (PVR), Visual Analogue Scale (VAS) to score the bother of urinary symptoms on QoL (0=worse; 10=best), Overactive Bladder questionnaire- Short Form (OAB-q SF). After face-to-face instruction in the use of the device, patients performed TPTNS therapy (Tensi+) at home, 20 minutes daily (as per protocol). Baseline evaluation was repeated at 1, 3 and 6- months f-up. 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.

Twenty OAB patients (15F, 5M) were enrolled with mean±SD age 43.3±22.8 y.o. The mean±SD duration of OAB symptoms before TPTNS was 5.8±1.3 y.o. No patient was on OAB therapy; all patients had PVR< 50ml. All patients experienced clinically meaningful improvement in OAB symptoms: at 3-months follow-up all subjects achieved the reduction in urgency, 16/20 (80%) improved day-time and night- time urinary frequency and 14/20 (70%) urgency incontinence episodes; these results were maintained at 6-months follow-up. No changes in UF parameters and PVR were noted during the f-up (p<1). Comparison of pre- and post-treatment OAB-q SF scores revealed a significant improvement of the total score (p<0.00). VAS score increased during the therapy and at the last follow-up (p<0.00). The objective success rate was 95%. The 4 patients with associated chronic pelvic pain reported a significant decrease of pain at 3-months follow-up (VAS p<0.0). No significant adverse events were observed.

This study showed that TPTNS was a safe and effective treatment for OAB in non-responder patients to previous conservative management. Urinary symptoms have already improved after 4 weeks of therapy and they were cured or significantly reduced within 6 months in vast majority of patients. The great advantages of this treatment were the non-invasiveness and the administration in the privacy at home. The limit could be that TPTNS should be repeated. However, our encouraging results may indicate that TPTNS could represent a step in the management of OAB in patients non-responder to first-line therapy before considering any invasive treatments. A further challenging question may be its use as a potential alternative initial therapy.

The home-based stimulation device (TPTNS, Tensi+) offers a safe and effective treatment for patients with OAB syndrome and improves QOL.