Outcomes of Posterior Tibial Nerve Stimulation Using TENSI+ Device for Lower Urinary Tract Symptom Management: A...

Transcutaneous posterior tibial nerve stimulation (TTNS) has emerged as a non-invasive therapeutic option for LUTS management in both sexes, yet long-term real-world data remain scarce. This study aimed to evaluate the long-term efficacy and safety of TENSI+ therapy and predictive factors associated with treatment response after mid-term follow-up.

We conducted a retrospective monocentric study including all patients treated with the TENSI+ device between August 2020 and January 2023. Data were collected from electronic medical records and standardized telephone interviews. Treatment efficacy was assessed using the Patient Global Impression of Improvement (PGI-I) scale at 3, 6, and 12 months. Kaplan-Meier analysis was used to evaluate treatment persistence. Multivariate logistic regression was performed to identify predictive factors of treatment response.

A total of 129 patients were included. At 12 months, 59% of patients reported treatment effectiveness (PGI-I ≤3). Improvement rates were 62% for urgency, 53% for urinary incontinence, 50% for voiding symptoms, and 55% for nocturia, whereas digestive symptoms showed minimal improvement (5%). Median treatment duration was 6 months, with a marked decline in adherence during the first 6 months followed by stabilization. Mild and reversible adverse events occurred in 8.5% of patients. Predictive factors of success identified through univariate analysis included the presence of voiding symptoms (p=0.028) and duration of use (p<0.001), but no independent predictive factors were identified in multivariate analysis.

TENSI+ represents a safe, well-tolerated, and effective therapy for LUTS management in a real-world setting. Level of evidence : 4.