Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Neurourol Urodyn. 2021 Jan;40(1):549-554. doi: 10.1002/nau.24596. Epub 2020 Dec 16.
To describe factors associated with satisfaction with the Axonics sacral neuromodulation (SNM) System at 1 year.
This was a secondary analysis of data collected in the ARTISAN-SNM study-a single arm, prospective, multicenter trial of the Axonics r-SNM System™. ARTISAN-SNM recruited participants with urgency urinary incontinence (UUI) to undergo a single, nonstaged implant of the lead and rechargeable neurostimulator. Participants were considered therapy responders if they had ≥50% reduction in UUI episodes in a 3-day period at 1-month post-implant. Bladder diaries and satisfaction (7-point Likert scale) were assessed at 1 year.
In all, 124 participants (110 "responders" and 14 "non-responders") had complete data at baseline, 1 month and 1 year following implant. Most participants were satisfied with Axonics at 1 year: 68.5% were "very satisfied," 25.8% were "moderately satisfied," and 2.4% were "slightly satisfied." At 1 year, treatment efficacy, as measured by electronic bladder diaries, was significantly associated with satisfaction. Participants who were "very satisfied" had a larger reduction in voids per day (p = .01), leaks per day (p = .004), urgent leaks per day (p = .04), and voids in which the urgency was desperate per day (p = .03) compared to those less satisfied. Twelve of the 14 "non-responders" continued to see improvements in symptom reduction from 1 month to 1 year; 9/14 (64%) were "responders" at 1 year with six reporting being "very satisfied" and one reporting being "moderately satisfied."
Satisfaction 1 year after implantation of Axonics SNM is extremely high and correlates with the degree of symptom improvement, which increases over time.
描述与 Axonics 骶神经调节（SNM）系统 1 年满意度相关的因素。
这是对 Axonics r-SNM 系统™的 ARTISAN-SNM 研究中收集的数据进行的二次分析。ARTISAN-SNM 招募了急迫性尿失禁（UUI）患者进行单次、非分期的引线和可充电神经刺激器植入。如果患者在植入后 1 个月的 3 天内 UUI 发作减少≥50%，则认为其为治疗反应者。在 1 年时评估膀胱日记和满意度（7 分 Likert 量表）。
共有 124 名参与者（110 名“反应者”和 14 名“非反应者”）在植入后基线、1 个月和 1 年时具有完整数据。大多数参与者在 1 年后对 Axonics 感到满意：68.5%“非常满意”，25.8%“满意”，2.4%“有点满意”。在 1 年时，以电子膀胱日记测量的治疗效果与满意度显著相关。“非常满意”的参与者每天的排尿量（p=0.01）、漏尿量（p=0.004）、每天急迫性漏尿量（p=0.04）和每天急迫性排尿量（p=0.03）的减少幅度更大。14 名“非反应者”中的 12 名从 1 个月到 1 年的症状缓解持续改善；14 名中有 9 名（64%）在 1 年时为“反应者”，其中 6 名报告“非常满意”，1 名报告“满意”。
Axonics SNM 植入后 1 年的满意度极高，与症状改善程度相关，且随时间推移而增加。
