A Prospective Study on the Effectiveness of Sensory and Sub-sensory Stimulation Amplitudes Using eCoin® Implantable Tibial Nerve Stimulation in Reducing Urgency Urinary Incontinence Episodes and Enhancing Quality of Life

TL;DR

This study shows that both sensory and sub-sensory stimulation settings of an implantable tibial nerve stimulation device reduce urgency urinary incontinence episodes and improve quality of life.

Contribution

The study introduces evidence that sub-sensory stimulation settings can be as effective as sensory settings in treating urgency urinary incontinence.

Findings

Sensory and sub-sensory stimulation groups both reduced UUI episodes by an average of 2.1 and 2.73 per day.

Both groups reported improved health-related quality of life and patient satisfaction.

Sub-sensory stimulation may enhance patient comfort and device longevity.

Abstract

Introduction

Urgency urinary incontinence (UUI), an important subset of overactive bladder (OAB), manifests with symptoms such as urgency, frequency, and incontinence, severely impacting quality of life. Neuromodulation therapies, including sacral nerve stimulation (SNM), percutaneous tibial nerve stimulation (PTNS), and implanted tibial nerve stimulation (ITNS), are FDA-approved for treating UUI. Traditional neuromodulation involves sensory and motor response evoking amplitudes, but emerging evidence suggests that sensory and sub-sensory settings might enhance treatment outcomes by influencing brain activation.

Aim

This study investigates the efficacy of sensory and sub-sensory programming of the eCoin® ITNS (Valencia Technologies Corporation, Valencia, California, USA) in reducing UUI episodes. The eCoin ITNS is a fully implantable device providing low-duty cycle tibial nerve stimulation.

Methods

The ESSENCE (Effectiveness of Sensory and Sub-sensory Stimulation Amplitudes Using eCoin Implantable Tibial Nerve Stimulation in Reducing Urgency Urinary Incontinence Episodes) study was conducted as a double-blind, randomized, controlled trial, and 36 subjects with UUI across five U.S. centers were enrolled, aiming to evaluate changes in UUI episodes and quality of life over three months. Participants were randomized to sensory or sub-sensory stimulation groups, with the sensory group activated to the amplitude at which stimulation was first felt and the sub-sensory group set 25% below this threshold. UUI episodes were recorded using three-day voiding diaries, and quality of life was assessed via the Overactive Bladder Symptom Quality of Life Questionnaire (OABq) to assess the primary endpoint of reduction from baseline in the number of UUI episodes per day on the three-day voiding diary.

Results

Results demonstrated a mean reduction in UUI episodes of 2.1 per day for the sensory group and 2.73 per day for the sub-sensory group from a pooled baseline of 5.53. Both groups reported improvements in health-related quality of life (HRQL) and patient satisfaction. These findings align with previous studies on SNM, demonstrating both sub-sensory and sensory settings are effective, potentially enhancing patient comfort and device longevity.

Conclusion

The ESSENCE study indicates that both sensory and sub-sensory amplitude settings of eCoin ITNS show a reduction in UUI episodes, improve quality of life, and increase patient satisfaction, offering the potential for optimizing neuromodulation therapies.

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