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Ambulatory Posterior Tibial Nerve Stimulation Using TENSI+ Device: First Clinical Study in Patients with Overactive
José Emilio Batista-Miranda1, Juan Francisco Monzón-Falconi1, Anaïs Bassas Parga1
1Department of Functional and Female Urology, Urodynamics Unit, Teknon Medical Center, 08022 Barcelona, Spain.
Background:
Overactive bladder (OAB) is a common condition characterised by urgency, frequency and nocturia, with a substantial effect in quality of life. Home-based posterior tibial nerve stimulation (PTNS) using the TENSI+ device represents a non-invasive alternative to conventional therapies. This study aimed to evaluate the short-term clinical effectiveness, feasibility and safety of home-based transcutaneous PTNS (T-PTNS) in patients with OAB and detrusor overactivity (DO).
Methods:
A prospective, single-arm study was conducted in Barcelona (September 2024-October 2025). Adults with OAB, defined in accordance with the International Continence Society criteria and urodynamic DO or cystometric capacity < 250 mL, received T-PTNS (10 Hz, 200 μs, individualised sensory threshold; 20 min/day, 5 days/week for 12 weeks). Outcomes included OAB-V8, OAB-V3, ICIQ-SF, Bladder Control Self-Assessment Questionnaire (BCSAQ) and safety and adherence. Logistic regression was used to identify predictors of early discontinuation.
Results:
Thirty-one patients were enrolled (mean age 70.5 ± 18.2 years; 58.1% women), and 71% completed the protocol. Significant improvements were observed from baseline to week 12 in OAB-V8 (24.0 → 13.1; p < 0.001), OAB-V3 (8.7 → 4.7; p < 0.001), ICIQ-SF (10.7 → 6.4; p = 0.019), BCSAQ-Symptoms (7.5 → 4.3; p < 0.001) and BCSAQ-Bother (8.1 → 5.0; p = 0.005). Clinical benefits were evident by week 4 and consolidated by week 12, with a consistent effect across sex subgroups. No device-related adverse events were reported. Early discontinuation was associated with baseline ICIQ-SF ≥ 12, BCSAQ ≥ and cystometric capacity < 200 mL.
Conclusions:
Home-based T-PTNS with the TENSI+ device resulted in significant short-term improvements in urgency, frequency and incontinence, with excellent safety and good adherence. Benefits emerged within 4 weeks, and they were sustained through 12 weeks, supporting TENSI+ as a feasible ambulatory neuromodulation option for selected patients with OAB. Larger randomised trials are warranted to confirm long-term efficacy and cost-effectiveness.