Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis.

Abstract

Introduction: Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US, and offer a new method of neurostimulation for the treatment of overactive bladder (OAB). In the absence of head-to-head studies, the aim of this meta-analysis was to indirectly compare the efficacy and safety of sacral neuromodulation (SNM) and implantable tibial neuromodulation (iTNM) for the treatment of OAB.

Methods: A comprehensive search was performed using terms for OAB and neuromodulation. Primary efficacy measures included a ≥ 50% reduction in urgency urinary incontinence (UUI) episodes, urinary frequency, and/or OAB symptoms. Primary safety measures included the rate of device-related adverse events (AEs).

Results: A total of 20 studies met selection criteria, encompassing 1416 patients treated with SNM and 350 patients treated with iTNM. No comparative or placebo-controlled studies for SNM and iTNM were identified, and therefore the analysis was completed using single-arm results. Weighted averages showed that the UUI responder rate was similar for both SNM and iTNM (71.8% and 71.3%, respectively). Similarly, weighted averages of OAB responder rates were 73.9% for SNM and 79.4% for iTNM. Similar rates of device-related AEs were also observed.

Conclusions: This meta-analysis found similar efficacy and safety of SNM and iTNM for the treatment of OAB and UUI, including UUI and OAB symptom response rates, reduction in UUI episodes, significant improvements in quality-of-life (QoL), and low rates of procedure and device-related adverse events. Notably, this comparable efficacy was seen without the use of a trial phase of neuromodulation in the iTNM studies versus SNM studies.