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Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

使用可充电SNM系统治疗尿失禁: ARTISAN-SNM研究的 6 个月结果。

  • 影响因子:1.46
  • DOI:10.1097/JU.0000000000000458
  • 作者列表:"McCrery R","Lane F","Benson K","Taylor C","Padron O","Blok B","De Wachter S","Pezzella A","Gruenenfelder J","Pakzad M","Perrouin-Verbe MA","Le Normand L","Van Kerrebroeck P","Mangel J","Peters K","Kennelly M","Shapiro A","Lee U","Comiter C","Mueller M","Goldman HB
  • 发表时间:2020-01-01
Abstract

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 System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® 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 performed an as-treated analysis in all implanted participants. RESULTS:At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS:The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

摘要

目的: 骶神经调节是指南推荐的治疗保守治疗失败患者的排尿功能障碍和大便失禁的方法。历史上,骶神经调节是使用平均寿命为 4.4 年的不可充电装置进行的。由于电池耗尽,需要手术更换植入的神经刺激器。植入长寿命的植入式神经刺激器可以消除替代手术的需要,潜在地降低患者手术风险和医疗保健成本。Axonics r-SNM系统™是一种小型化、可充电的骶神经调节系统,旨在提供至少 15 年的治疗。The ARTISAN-SNM (Axonics®骶神经调节系统治疗尿失禁) 研究是使用可充电骶神经调节疗法治疗尿失禁的一项关键研究。呈现六个月的结果。 材料和方法: 共治疗 129 例符合条件的急迫性尿失禁患者。所有参与者均在非分期手术中植入着色电极导线和可充电骶神经调节系统。使用 3 天膀胱日记、经验证的ICIQ-OABqol (国际尿失禁咨询问卷膀胱过度活动症生活质量) 问卷和参与者满意度问卷收集疗效数据。治疗应答者被确定为与基线相比尿急迫性尿失禁发作减少 50% 或更多的参与者。我们对所有植入的参与者进行了治疗分析。 结果: 在 6 个月时,90% 的参与者是治疗应答者。每天平均 ± SE次的尿失禁发作次数从基线时的 5.6 ± 0.3 减少到 1.3 ± 0.2。参与者在ICIQ-OABqol问卷上经历了有临床意义的 34 分改善。没有严重的设备相关不良事件。 结论: Axonics r-SNM系统是安全有效的,90% 的参与者在急迫性尿失禁症状方面有临床和统计学上的显著改善。

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来源期刊:Clinical nephrology
DOI:10.5414/CN109735
作者列表:["Battaglia Y","Cojocaru E","Fiorini F","Granata A","Esposito P","Russo L","Bortoluzzi A","Storari A","Russo D"]

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翻译标题与摘要 下载文献
影响因子:1.46
发表时间:2020-01-01
来源期刊:The Journal of urology
DOI:10.1097/JU.0000000000000461
作者列表:["Lee J","Kim HY","Goh HJ","Heo JE","Almujalhem A","Alqahtani AA","Chung DY","Chang K","Choi YD","Rha KH"]

METHODS:PURPOSE:We compared early continence recovery after surgical treatment of prostate cancer with Retzius sparing robot-assisted radical prostatectomy and conventional robot-assisted radical prostatectomy. MATERIALS AND METHODS:Robot-assisted radical prostatectomy was done by a single surgeon in 1,863 cases between October 2005 and May 2018 using the conventional and the Retzius sparing technique in 1,150 and 713, respectively. To compare continence outcomes between the groups propensity score matching was performed using 9 preoperative variables, including age, body mass index, prostate specific antigen, biopsy Gleason Grade Group, clinical T stage, prostate volume on transrectal ultrasound, and the I-PSS (International Prostate Symptom Score), I-PSS quality of life score and International Index of Erectile Function-5 scores. Continence was assessed by the pad count every month postoperatively until month 6 and was converted to a binary outcome. RESULTS:After propensity score matching 609 cases per group were matched with no significant difference in all 9 variables. The Kaplan-Meier curve analysis revealed that Retzius sparing robot-assisted radical prostatectomy was associated with a significantly better continence recovery rate than conventional robot-assisted radical prostatectomy during the 6-month study period (p <0.001). CONCLUSIONS:Based on propensity score matching with multiple variables and a large case series, Retzius sparing robot-assisted radical prostatectomy can be a candidate for future robot-assisted radical prostatectomy. It achieves better early continence recovery, a short operative time and early recovery compared to conventional robot-assisted radical prostatectomy.

翻译标题与摘要 下载文献
影响因子:1.46
发表时间:2020-01-01
来源期刊:The Journal of urology
DOI:10.1097/JU.0000000000000458
作者列表:["McCrery R","Lane F","Benson K","Taylor C","Padron O","Blok B","De Wachter S","Pezzella A","Gruenenfelder J","Pakzad M","Perrouin-Verbe MA","Le Normand L","Van Kerrebroeck P","Mangel J","Peters K","Kennelly M","Shapiro A","Lee U","Comiter C","Mueller M","Goldman HB"]

METHODS: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 System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® 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 performed an as-treated analysis in all implanted participants. RESULTS:At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS:The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

排尿障碍方向

因为输尿管阻塞等原因,导致排尿不顺畅或者无法排尿的症状。

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