Abstract：
The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence-based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single-blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment.
Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis.
Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting \"much better\" or \"very much better\" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting \"much better\" or \"very much better\" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications.
Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.
Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis.
Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting \"much better\" or \"very much better\" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting \"much better\" or \"very much better\" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications.
Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.
摘要：
背景：骶神经调节（SNM）中的脉冲宽度（PW）参数研究不足，没有关于泌尿适应症的最佳PW的循证指导。这个前瞻性的目标，随机化，单盲,3×3交叉设计研究是为了估计两种PW设置的影响(60µs，420µs）与SNM功效的行业标准（210µs）相比，生活质量,和对SNM治疗稳定和满意的患者的设备参数。
方法：符合条件的患者先前进行了植入，并且在招募时对SNM感到满意，有急迫性尿失禁或尿急频率。患者完成了3天的排尿日记，经过验证的问卷，在基线和在三个PW设置中的每一个设置4周后进行感觉阈值评估的装置询问,他们被随机分配。18名参与者完成了这项研究，正如权力分析所要求的那样。
结果：18名患者纳入研究。平均年龄为68岁，参与时的植入时间为4.4年。虽然PW变化在总体目标结果中没有产生显著差异，设备参数,包括感觉阈值振幅和电池寿命差异显著。缩短的PW需要更高的振幅,同时节省电池寿命。刺激感觉位置,质量,PW之间的强度没有差异。11名患者在研究后选择了标准PW，5选择了扩展，和2选择缩短。那些选择替代PW的人从注册-2.23个空隙/天（p=0.015）获得了尿频的显着减少。根据子分析，与基线时的8.5和2.16相比,报告延长PW“好得多”或“非常好”的患者在5.6和0.4时的尿频和夜尿显著减少(p=0.005,p=<0.001).而那些在缩短PW上报告“好得多”或“非常好”的人在5.15与7.35相比实现了尿频的显着减少（p=0.026）。无不良事件或并发症发生。
结论：替代PW的SNM总体有效性没有变化；然而，39％的患者更喜欢标准PW的替代方法，并且这种方法在泌尿症状方面取得了显着改善。更短的PW还可以在不牺牲治疗功效的情况下提供估计的电池寿命的节省。
方法：符合条件的患者先前进行了植入，并且在招募时对SNM感到满意，有急迫性尿失禁或尿急频率。
结果：18名患者纳入研究。
结论：替代PW的SNM总体有效性没有变化；然而，
