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骶神经刺激治疗排尿功能障碍:一家机构的11年经验。

Sacral nerve stimulation for voiding dysfunction: One institution's 11-year experience.

作者信息

Sutherland Suzette E, Lavers Ann, Carlson Angeline, Holtz Cindy, Kesha Jyothi, Siegel Steven W

机构信息

Metro Urology, Center for Continence Care and Female Urology, Minneapolis/St. Paul, Minnesota 55441, USA.

出版信息

Neurourol Urodyn. 2007;26(1):19-28; discussion 36. doi: 10.1002/nau.20345.

DOI:10.1002/nau.20345
PMID:17078071
Abstract

AIM

The purpose of this study was to review our institution's 11-year experience with SNS for the treatment of refractory voiding dysfunction. Dating back to 1993, it covers a span of time which describes the evolution of SNS as it includes PNE trials, non-tined (bone-anchored or fascial-anchored) leads, percutaneous tined leads with two-staged procedures, and even percutaneous pudendal trials.

METHODS

A retrospective review was performed on SNS patients who received an implantable pulse generator (IPG) in our practice from 12/1993 to 12/2004. After Institutional Review Board approval, consents for chart review were obtained from 104 patients, representing 44% of this neuromodulatory patient population.

RESULTS

Of our population, 87% were female and 13% were male. Average age at implant was 50 years +/- 13.4 years. Duration of symptoms before implantation was 116 months (range 9-600 months). Eighty percent were implanted for a predominant complaint of urinary urgency and frequency (U/F). Overall, 22% had U/F only, 38% had concomitant urge incontinence (UI), and 20% had concomitant mixed incontinence (MI). Twenty percent were treated for non-obstructive urinary retention (UR), with half of these associated with a neurogenic etiology. Additionally, 46.2% had pelvic pain, 58.6% had bowel complaints, and 51% reported sexual dysfunction. In patients with U/F, mean voiding parameters as described by pre-implant voiding diaries revealed the following: 12.4 (+/-5.1) voids per 24 hr; 2.3 (+/-1.8) voids per night; 5.0 (+/-4.7) leaks per 24 hr; and 2.3 (+/-2.6) pads per 24 hr. Statistically significant improvements post-implantation were noted with mean decreases in the following: 4.3 voids per 24 hr; 1.0 void per night; 4.4 leaks per 24 hr; and 2.3 pads per 24 hr (all P < 0.05). In the UR group a statistically significant improvement post-implantation was noted only in voids per night, with a mean decrease of 0.8 (P < 0.05). With a mean follow up of 22 months (range 3-162 months), sustained subjective improvement was >50%, >80%, and >90% in 69%, 50%, and 35% of patients, respectively. By quality of life survey, 60.5% of patients were satisfied and 16.1% were dissatisfied with current urinary symptoms. Only 13% (14 patients) abandoned therapy, making up a significant portion of those dissatisfied with current urinary symptoms. Good overall lead durability was seen (mean 22 months, range 1-121 months), with the first successful lead proving to be the most durable (mean 28 months, range 1.4-120 months). Lead durability decreased progressively with subsequent trials. Overall, 53% of patients experienced at least one reportable event (RE) attributable to either lead or IPG. A total of 126 REs were noted, with 97% mild-to-moderate in severity. REs included lack of efficacy, loss of efficacy, infection, hematoma/seroma, migration, pain, undesirable change in sensation, and device malfunction. In this population, 47.1% of leads were tined while 52.9% were non-tined. Tined leads had an overall lower RE rate as compared to non-tined leads: 28% and 73%, respectively.

CONCLUSIONS

SNS is an effective method for treating certain types of voiding dysfunction. Although 53% of patients experienced at least one RE, 97% were mild-to-moderate and did not appear to affect the continued use of this therapy. With improved technology, such as percutaneous tined leads, the RE rate is decreasing. Further analyses of subsets of this population are currently underway.

摘要

目的

本研究旨在回顾我院11年来使用骶神经刺激(SNS)治疗难治性排尿功能障碍的经验。自1993年起,涵盖了一段时间跨度,这段时间描述了SNS的发展历程,包括阴部神经电刺激(PNE)试验、非倒刺(骨锚定或筋膜锚定)电极、经皮倒刺电极及两阶段手术,甚至经皮阴部神经试验。

方法

对1993年12月至2004年12月期间在我院接受植入式脉冲发生器(IPG)的SNS患者进行回顾性研究。经机构审查委员会批准,获取了104例患者的病历审查同意书,占该神经调节患者群体的44%。

结果

在我们的研究人群中,87%为女性,13%为男性。植入时的平均年龄为50岁±13.4岁。植入前症状持续时间为116个月(范围9 - 600个月)。80%的患者因主要的尿急和尿频(U/F)症状而植入。总体而言,22%仅有U/F症状,38%伴有急迫性尿失禁(UI),20%伴有混合性尿失禁(MI)20%的患者因非梗阻性尿潴留(UR)接受治疗,其中一半与神经源性病因有关。此外,46.2%有盆腔疼痛,58.6%有肠道问题,51%报告有性功能障碍。在U/F患者中,植入前排尿日记记录的平均排尿参数如下:每24小时12.4(±5.1)次排尿;每晚2.3(±1.8)次排尿;每24小时5.0(±4.7)次漏尿;每24小时2.3(±2.6)片尿垫。植入后观察到统计学上的显著改善,平均减少如下:每24小时4.3次排尿;每晚1.0次排尿;每24小时4.4次漏尿;每24小时2.3片尿垫(所有P < 0.05)。在UR组中,植入后仅在每晚排尿次数上有统计学上的显著改善,平均减少0.8次(P < 0.05)。平均随访22个月(范围3 - 162个月),分别有69%、50%和35%的患者主观持续改善率>50%、>80%和>90%。通过生活质量调查,60.5%的患者对当前泌尿症状满意,16.1%不满意。仅13%(14例患者)放弃治疗,占对当前泌尿症状不满意患者的很大一部分。观察到良好的总体电极耐用性(平均22个月,范围1 - 121个月),首次成功植入的电极最耐用(平均28个月,范围1.4 - 120个月)。随着后续试验,电极耐用性逐渐降低。总体而言,53%的患者经历了至少一次可报告事件(RE),该事件可归因于电极或IPG。共记录到126次RE,其中97%为轻度至中度严重程度。RE包括疗效不佳、疗效丧失、感染、血肿/血清肿、移位、疼痛、感觉异常变化和设备故障。在该人群中,47.1%的电极是倒刺电极,52.9%是非倒刺电极。与非倒刺电极相比,倒刺电极的总体RE发生率较低:分别为28%和73%。

结论

SNS是治疗某些类型排尿功能障碍的有效方法。尽管有高达53%的患者经历了至少一次可报告事件,但97%为轻度至中度,似乎并不影响该治疗方法的持续使用。随着技术改进,如经皮倒刺电极,可报告事件发生率正在降低。目前正在对该人群的亚组进行进一步分析。

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