Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice

Abstract

Objectives: In some patients treated for urinary or fecal incontinence with sacral neuromodulation (SNM) persistence of symptoms, a reduction in efficacy or adverse effects of stimulation can occur. In such situations, further programming of the SNM device can help resolve problems. Infrequently hardware failure is detected. This article aims to provide practical guidance to solve sub-optimal outcomes (troubleshooting) occurring in the course of SNM therapy. Materials and Methods:A systematic literature review was performed. Collective clinical experience from an expert multidisciplinary group was used to form opinion where evidence was lacking.Results: Circumstances in which reprogramming is required are described. Actions to undertake include changes of electrode configuration, stimulation amplitude, pulse frequency, and pulse width. Guidance in case of loss of efficacy and adverse effects of stimulation, developed by a group of European experts, is presented. In addition, various hardware failure scenarios and their management are described.Conclusions: Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.

Is sacral nerve modulation reprogramming effective after permanent implantation for faecal incontinence?

“…However, few studies have evaluated the effectiveness of reprogramming on patient-reported events. The present study demonstrated that stimulator reprogramming is mostly effective and makes it possible to maintain the effectiveness of the treatment midline sensation with a low-amplitude stimulation or decrease the amplitude of stimulation in the event of pain or discomfort and (4), if unsuccessful, redefine the optimum electrode configuration using the initial basic programming principles (Figure 1) [16].…”

“…When events related to the stimulation (i.e. loss of efficacy and/or an adverse event) were reported, the stimulation settings were changed using the following procedure: (1) check to make sure that the IPG is switched ‘ON’, (2) check the impedance to test the integrity of the system, (3) increase the amplitude of the stimulation to obtain a midline sensation with a low‐amplitude stimulation or decrease the amplitude of stimulation in the event of pain or discomfort and (4), if unsuccessful, redefine the optimum electrode configuration using the initial basic programming principles (Figure 1) [16].…”

“…After implantation of a SNM device, the efficacy of and possible adverse events related to electrical stimulation can be re-evaluated on a regular basis [15,16] as reprogramming of the stimulator may be required to maintain its efficacy [15,16]. However, only a limited number of studies have investigated the impact of reprogramming on optimizing the therapy [17,18].…”

Data Gap in Sacral Neuromodulation Documentation: Call to Improve Documentation Protocols

“…The overall success rate for SNM ranges from 43% to 85% [10] and revision rates for an initial suboptimal outcome range from 3%-35% [11]. Reasons for therapy failure include lead migration [12,13], hardware failure [11], patient selection [14], and adverse effects such as unwanted stimulation, discomfort, or loss of efficacy, often leading to reprogramming of the device [11].…”

“…The overall success rate for SNM ranges from 43% to 85% [10] and revision rates for an initial suboptimal outcome range from 3%-35% [11]. Reasons for therapy failure include lead migration [12,13], hardware failure [11], patient selection [14], and adverse effects such as unwanted stimulation, discomfort, or loss of efficacy, often leading to reprogramming of the device [11]. Reprogramming and documentation of thresholds, efficacy and therapy settings are essential to understanding and im-proving therapy failures, surgical revisions and device designs needed to address these therapy issues.…”