Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance (original) (raw)
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European Urology Supplements, 2018
The RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time. Methods: Fifty-one OAB patients were implanted in a single-stage procedure. These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires. Results: Forty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit. Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14-day recharge intervals (time between charging) and 98% of subjects had ≥7-day recharge interval. No charging related adverse events occurred. Conclusions: Study subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy.
Journal of Urology, 2019
Purpose: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM SystemÔ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (AxonicsÒ Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. Materials and Methods: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We
Neurourology and Urodynamics, 2007
Aims: To evaluate long-term patient satisfaction of sacral neuromodulation and to correlate satisfaction with incontinence parameters. Methods: Patients at least 1-year remote from sacral neuromodulation were mailed a questionnaire to evaluate satisfaction and assess incontinence symptoms. Results: Fifty-two patients were consecutively enrolled in the study. Forty-nine questionnaires (94.2%) were returned. The average interval between implantation and questionnaire completion was 27.2 (range 12^52) months. 83.7% of respondents were satis¢ed and 79.6% of patients would '' do it all over again. '' Compared to dissatis¢ed subjects during test stimulation, the satis¢ed patients had a signi¢cant decrease in 24-hr pad weight (84.5% vs. 60.6%, P ¼ 0.002) but did not di¡er in daily pad usage (4.5 fewer pads per day vs. 3.4, P ¼ 0.190). At long-term follow-up, satis¢ed patients noted signi¢cantly greater improvement in their Incontinence Impact Questionnaire score versus dissatis-¢ed patients (mean improvement 53 vs. 10 points, P ¼ 0.0003). Using multiple logistic regression, change in 24-hr pad weight, but not change in average daily pad usage, was correlated with longterm satisfaction. Conclusions: Eighty-four percent of patients were satis¢ed with sacral neuromodulation at a mean of 27 months. An 84.5% reduction in 24-hr pad weight correlated with long-term patient satisfaction. In addition to lack of e⁄cacy, device pain was a contributing factor to dissatisfaction. Neurourol. Urodynam. 26:213^217, 2007. ß 2006
Urgent‐SQ implant in treatment of overactive bladder syndrome: 9‐year follow‐up study
Neurourology and Urodynamics, 2012
AimsElectrical stimulation of the posterior tibial nerve (PTN) is an established therapy for the treatment of refractory overactive bladder syndrome (OAB). The Urgent‐SQ™ is an implant that is surgically placed near the PTN and activated by an external pulse generator, allowing for “on demand” PTN stimulation, without the need for needle insertion. The current study presents results of a 9‐year, open‐label, follow‐up of eight patients to address the long term safety and efficacy of the implant.MethodsIn 2003, eight patients with refractory OAB received a Urgent‐SQ™ implant and were systematically followed up for 1 year. After that, the follow up continued as open‐label study. The seven patients who still had the implant were contacted after 9 years and evaluated with an interview, physical exam, ankle X‐ray, voiding diaries, and completed questionnaires about adverse events, performance, efficacy, safety, and quality of life (validated iQoL).ResultsSix of the seven patients still ha...