A pilot sham-controlled study to evaluate the safety and efficacy of a novel wearable microneedle percutaneous neuromodulation system for idiopathic overactive bladder and urinary incontinence

Abstract

INTRODUCTION & OBJECTIVES: Clinicbased percutaneous tibial nerve stimulation (PTNS) is established therapy for idiopathic overactive bladder (OAB) and urge urinary incontinence however weekly clinic visits, variable needle placement, and broad access to therapy limit real world uptake. We developed a minimally invasive, wearable microneedle system designed standardise tibial nerve targeting adjacent to the medial malleolus and enable self administration at home. This first in human randomised pilot study characterises and reports on early performance signals versus sham stimulation utilising this novel technology. METHODS: This is a prospective, randomised, single blind, sham controlled feasibility study at two Australian sites enrolling adults with idiopathic OAB and/or urge urinary incontinence and eligible for third line therapy. Human research ethics has been granted by Bellberry Limited and the study is conducted in accordance with ISO 14155, ICH GCP, and the Declaration of Helsinki. Participants are randomised 3:1 active or sham. The intervention comprises twelve weekly 30 min sessions delivered via the minimally invasive wearable microneedle system. The device design guides consistent placement of the percutaneous microneedle system superficial to the tibial nerve, and the stimulator delivers biphasic current similar to currently available PTNS devices while adherence is logged via a Bluetooth enabled app and onboard inertial sensor. The sham arm follows an identical workflow without current delivery. Primary objectives assess change from baseline in average incontinence episodes per day and voids per day at weeks 6 and 12. Exploratory outcomes include PGI C, OAB Symptom Score, ICIQ, SF 12, post session pain on a visual analogue scale, skin integrity, and compliance. 40 participants will be enrolled. Efficacy endpoints for reduction in frequency and incontinence episodes will report on quantitative measures assessing median change from baseline to Week-12 post commencement of therapy and utilising a mixed-effects analysis of variance (ANOVA) with a = 0.05. The intention to treat population will be primary, with prespecified per protocol sensitivity analyses. RESULTS: Enrollment, randomization, therapy and follow-up are ongoing at the time of submission. Prespecified outcomes include safety events related to microneedle insertion and changes in bladder diary metrics, compliance, patient reported outcomes and blinded between group comparisons will be completed and presented. Pretrial product testing data obtained the following results. CONCLUSIONS: This novel minimally invasive, home based microneedle PTNS platform is intended to reduce treatment burden and improve placement consistency relative to clinic based PTNS. If this feasibility study demonstrates safety with encouraging symptom trends, it will justify a subsequent pivotal trial to evaluate comparative effectiveness and durability and may broaden access to neuromodulation for OAB.