Neurourology and urodynamics
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Multicenter Study
A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.
Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. ⋯ The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.
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Sacral neuromodulation (SNM) is an established minimally invasive therapy for functional disorders of the pelvic organs in which electrodes are stimulated in proximity of the sacral spinal nerves. Reprogramming of the electrodes is regularly required and is based on the sensory response. This study assesses the repeatability of a pelvic chart and grading system to enable a more objective assessment of the sensory response upon electrode stimulation. ⋯ The pelvic chart and grading system, using the sensory response upon electrode stimulation, are repeatable tools and can be used to assist in follow up and troubleshooting of SNM patients.