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Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance.

ABSTRACT: The Axonics sacral neuromodulation (SNM) system can be used by people with refractory overactive bladder (OAB) to reduce symptoms of urge urinary incontinence and urinary frequency, where conservative treatments have failed or are not suitable. It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications. We describe the evidence considered by the UK National Institute of Health and Care Excellence (NICE) in their evaluation of this evidence, supported by Cedar Healthcare Technology Research Centre. Two observational studies provided descriptive data that suggested improvement in control of symptoms after implantation of the Axonics SNM system; however, there was no peer-reviewed evidence that directly compared rechargeable and non-rechargeable SNM systems. In the absence of long-term data, economic modelling relies on the accuracy of battery life estimates. The evidence supports the case for adopting the Axonics SNM system for treating refractory OAB, when conservative treatment or treatment with medicines has not worked. This conclusion is consistent with other relevant NICE guidelines. Use of Axonics SNM technology in the UK National Health Service (NHS) is associated with a potential cost saving of £6025 per person over a 15-year period when compared with an equivalent non-rechargeable SNM system, assuming the claimed battery life estimate (a minimum of 15 years) is accurate. The cost savings are estimated to start around 6 years after implantation.

SUBMITTER: Poole RL

PROVIDER: S-EPMC9021055 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance.

Poole Ruth Louise RL Dale Megan M Morgan Helen H Oladapo Tosin T Brookfield Rebecca R Morris Rhys R

Applied health economics and health policy 20211229 3

The Axonics sacral neuromodulation (SNM) system can be used by people with refractory overactive bladder (OAB) to reduce symptoms of urge urinary incontinence and urinary frequency, where conservative treatments have failed or are not suitable. It is the first system for this indication that makes use of a rechargeable battery to prolong the lifespan of the implanted device, with the potential advantage of reducing the frequency of surgical replacement procedures and associated complications. We ...[more]

PMID: 34964090

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Project description:Overactive bladder (OAB) is a common urological disease, reducing patient quality of life (QoL). Sacral neuromodulation (SNM) is a treatment option used when conservative treatment is inadequate. However, constant frequency stimulation-SNM (CFS-SNM) may not be sufficiently effective in achieving targeted symptom reduction in some patients. For such black-zone patients, a different treatment strategy is needed. Variable frequency stimulation (VFS) has been used for deep-brain stimulation treatment in patients with Parkinson's disease with positive outcomes. Accordingly, in this study, we hypothesized the promising outcomes of VFS-SNM in black-zone OAB patients. Here, we evaluated the efficacy and safety of VFS-SNM viz-a-viz CFS-SNM in a black-zone patient with refractory OAB whose frequent micturition symptoms were not relieved after undergoing traditional conservative treatment. A 50-year-old male patient was treated with CFS-SNM at our hospital in October 2016, but his symptoms recurred after administering multiple medications and program-controlled parameter adjustments. We then treated the patient with VFS-SNM in March 2020. A 2-week follow-up through telephonic interviews was conducted; the improvements in voiding symptoms were evaluated by calculating the OAB symptom score (OABSS) and OAB-related QoL (OAB-QoL) score. We observed that OABSS was significantly lower after VFS-SNM than after CFS-SNM. Further, we observed that VFS-SNM significantly improved daytime and nocturnal micturition frequency, as evident from the reduced OABSSs from after CFS-SNM to after VFS-SNM. The main reason for patient dissatisfaction after CFS-SNM was the increased average daily micturition frequency and urgency. VFS-SNM controlled the micturition frequency to within the patient's acceptable range, significantly improving the patient's QoL (40% improvement in OAB-QoL score). To the best of our knowledge, this is the first case report on the use of VFS-SNM with positive outcomes in a black-zone OAB patient, suggesting that VFS-SNM is not inferior to CFS-SNM in the treatment of black-zone patients.

Dataset Information

Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance.

Publications

Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance.

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