Transcutaneous posterior tibial nerve stimulation (T-PTNS) is a non-invasive neuromodulation technique that may facilitate a more accessible management of urinary disorders. Aim of this study was to assess the clinical safety and therapeutic efficacy of T-PTNS in patients with overactive bladder (OAB) refractory to previous conservative treatments, evaluating outcomes over a medium-term follow-up period.

This single-centre prospective study included male and female OAB patients non-responsive to pharmacological therapy. Baseline evaluation comprised a 3-day bladder diary, urodynamics (UD), Visual Analogue Scale (VAS, 0= worse; 10= best) to score urinary symptom bother, and Overactive Bladder questionnaire- Short Form (OAB-q SF). After a face-to-face training session, patients performed T-PTNS (Tensi+) at home, 20 minutes daily (as per protocol). Baseline evaluation was repeated at 1, 3, 6, and 12- months; UD was repeated at the 12-mos f-up. Treatment success was defined as >50% reduction in urgency episodes (with or without urgency incontinence) or > 30% reduction in 24-hour voiding frequency.

Thirty-two OAB patients (6 males, 26 females; mean age: 61.4 ± 18.8 y.o.) were enrolled. Mean ± SD duration of OAB symptoms was 5.9 ± 3.9 years. No patient was receiving OAB medication at baseline and all had post-void residual volume (PVR) < 50 mL. All patients experienced clinically meaningful symptoms improvement. At 3-mos f-up, urgency episodes decreased in all subjects; 28/32 (87.5%) improved day- and night-time urinary frequency and 24/32 (75%) reported reduced urgency incontinence episodes. Benefits were maintained at the 12-mos f-up. At 12-mos UD f-up, patients showed an increase in maximum cystomanometric capacity and in the volume at first uninhibited detrusor contraction (p<0.001), while PVR remained stable (p>0.1). OAB-q SF total scores significantly improved (p<0.001), and patient satisfaction assessed by VAS increased and remained stable at last f-up (p<0.001). Overall treatment success rate was 95%. Among three patients with associated chronic pelvic pain, pain intensity significantly decreased at 3-mos f-up (VAS, p<0.001). No significant adverse events occurred.

T-PTNS proved safe and effective in OAB patients refractory to previous therapy, with urinary symptoms improvement evident within approximately 6 weeks and sustained over time. The main advantages of T-PTNS include its non-invasiveness, good tolerability, and the possibility of home-based administration, which may improve patient compliance and accessibility to treatment. A potential limitation of T-PTNS is the need for repeated treatment cycles to maintain long-term efficacy. However, the encouraging results observed may represent an effective step in the therapeutic pathway of OAB, particularly in patients who are unsuitable for or reluctant to undergo invasive treatments. A further challenging question may be its use as a potential alternative initial therapy.

The home-based stimulation device (T-PTNS, Tensi+) offers a safe, well-tolerated, and effective treatment for patients with OAB, leading to significant symptom improvement and enhanced quality of life.