Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder
Abstract
PURPOSE: The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM((R))) in patients with overactive bladder (OAB). METHODS: This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM((R)).
The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM((R)).
The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM((R)). Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation.
RESULTS: The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM((R)) was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017).
CONCLUSION: The treatment effect achieved during the initial phase of peroneal eTNM((R)) persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.