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

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.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.