Peroneal electric transcutaneous neuromodulation versus solifenacin in the treatment of the overactive bladder wet

Abstract

Introduction Peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM (R)) is a non-invasive treatment for overactive bladder (OAB). In the previous randomized study in female patients with OAB, both dry and wet, peroneal eTNM (R) demonstrated significantly better safety and comparable efficacy to solifenacin. This subgroup analysis aimed to compare the safety and efficacy of peroneal eTNM (R) versus solifenacin in OAB wet population. Material and methods In the primary study, eligible subjects were randomized in a 2 : 1 ratio to receive either 12 weeks of daily peroneal eTNM (R) for 30 minutes or solifenacin 5 mg daily. This subgroup analysis included participants who presented with at least one incontinence episode at baseline and completed the study according to protocol. The primary endpoint was safety, secondary endpoint was proportion of continent subjects after treatment. Additional efficacy assessments included change in bladder diary variables, OAB V8 score, and quality of life (QoL). Results In the peroneal eTNM (R) group (n = 26), three treatment-related adverse events (TRAEs) were recorded, while nine TRAEs occured in the solifenacin group (n = 16). The proportion of patients who achieved continence after 4, 8 and 12 weeks of treatment was 50%, 62%, and 65% in the peroneal eTNM (R) and 56%, 50%, and 56% in the solifenacin group, respectively. Both treatments led to significant and similar improvements in all bladder diary variables, OAB V8 score, and QoL. Conclusions The results of this secondary analysis confirm that peroneal eTNM (R) has significantly better safety profile and comparable efficacy versus solifenacin in the subgroup of incontinent OAB patients.