Predictive factors of clinical success for treatment of urgency urinary incontinence using implantable tibial neuromodulation

Implantable tibial Neuromodulation (iTNM) is an emerging therapy for overactive bladder (OAB). In the Revi® system (BlueWind Medical), the implanted electrode is activated through an external wearable. This study aims to identify characteristics tied to a positive clinical response. The OASIS Study was a prospective, multicentre, single arm trial, evaluating Revi in adult females with urgency urinary incontinence. Baseline characteristics and voiding diaries at 1, 3, 6, 9, and 12months were analyzed. Multivariate logistic regression identified predictors of response, with significance set at p < 0.05. A total of 151 participants were implanted, with 135-146 providing voiding diaries throughout 12 months of follow-up. The overall success rate at 12 months was 82%. Prior use of OAB medication was a positive predictor of success at 6, 9 and 12 months (OR; 3.31, 5.14, 4.51, respectively). Larger leg circumference (>23 cm) predicted lower odds of success at 3 months (OR 0.16) and 6 months (OR 0.28). And BMI > 30kg/m 2 was negatively associated at 9- and 12-months (OR 0.30 and OR 0.29, respectively). Presence of large leaks reduced odds of success at all timepoints, except for 12 months (OR range 0.15 – 0.5). Baseline quality of life was associated with success, though not linearly. Most female participants benefited from the Revi System treatment. Larger leg circumference and higher BMI predicted lower success at early and later timepoints, respectively. Large leaks were modestly associated with poorer outcomes. Recent OAB medication use predicted better treatment response.