MINNEAPOLIS (EGMN) – Improvements in fecal incontinence achieved with sacral nerve stimulation appear to persist up to 3 years, based on the results of a study involving 133 patients.

Among 77 patients who were implanted with the InterStim device and followed for 3 years, therapeutic success – defined as at least a 50% reduction in the number of incontinent episodes per week – was 86%, Dr. Anders Mellgren reported at the annual meeting of the American Society of Colon and Rectal Surgeons. The study was supported entirely by Medtronic Inc., which makes the InterStim device.

The researchers included 133 patients who were experiencing chronic fecal incontinence of at least two episodes per week and who had an external anal sphincter defect of less than 60 degrees. In addition, these patients either were not candidates for more conservative treatments or had failed such attempts.

The sacral nerve stimulation procedure is a two-step process. The patient is first implanted with a test lead for a 1- to 2-week trial. If incontinent episodes are reduced by at least 50%, the stimulation device is implanted. In this study, following the initial test period, 120 patients were implanted with the InterStim device. The device delivers mild electrical stimulation to the sacral nerves that control the bladder, sphincter, and pelvic floor muscles.

Patients were asked to record their total number of incontinent episodes per week, total urgent incontinent episodes per week, and total incontinent days per week. Data were recorded at 3 months, 6 months, and 12 months, and annually thereafter. The average total follow-up period was 28 months, said Dr. Mellgren, an adjunct professor of colon and rectal surgery at the University of Minnesota in Minneapolis.

Depending on the type of analysis performed, the success rate ranged from 59% to 86%, Dr. Mellgren said. A total of 77 patients completed treatment and had a 3-year follow-up period. Success in these patients was 86%. However, when all the implanted patients were included and the last observation was carried forward, the success rate was 79%. And in a modified worst-case analysis, all patients who did not complete the follow-up period were considered failures, so the success rate dropped to 59%.

The average number of incontinent episodes per week decreased from almost 10 at baseline to about 2 at the end of 3 years (77 patients). In addition, perfect continence (100% improvement) was achieved in about 40% of the patients, while 20%-30% of patients had a 75% improvement in symptoms.

The most common device- or therapy-related adverse events that occurred during the implant phase of the study were implant site pain (28% of patients), paresthesia (15%), change in sensation of stimulation (12%), and implant site infection (10%). Half of the patients with infection had to be reoperated, and five had the device removed, Dr. Mellgren noted. Most events were successfully handled by minimal interventions.

Three of the authors, including Dr. Mellgren, reported receiving research support from and acting as consultants to Medtronic. One of the authors is an employee of Medtronic.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

明尼阿波利斯(EGMN)——一项纳入了133例患者的试验结果表明，骶神经刺激术对大便失禁的改善作用可持续3年之久。

 

Anders Mellgren博士在美国结直肠外科医师协会2010年年会上报告称，在植入了InterStim装置并接受了3年随访的77例患者中，治疗成功率达到了86%。治疗成功定义为每周失禁次数至少减少了50%。该试验完全由美敦力公司资助，美敦力是InterStim装置的生产商。

 

研究者纳入了133例每周至少发作2次且肛门外括约肌缺损小于60度的慢性大便失禁患者。此外，这些患者要么不适合接受更加保守的治疗，要么已经接受过保守治疗但治疗失败。

 

骶神经电刺激术共分为2步。先植入一根测试导线观察1~2周。如果大便失禁的次数至少减少了50%， 则进而植入刺激装置。在该试验中，初始试验期之后，共有120例患者植入了InterStim装置。该装置会向控制膀胱、括约肌和盆底肌肉的骶神经发送轻微的电刺激。

 

美国明尼阿波利斯明尼苏达大学的结直肠外科副教授Mellgren博士说，要求患者记录下每周失禁的总次数、每周急迫性失禁的总次数以及每周失禁的总天数。治疗后3个月、6个月、12个月，之后每年收集一次数据。总平均随访期为28个月。

 

Mellgren博士说，根据所开展的分析类型，治疗成功率在59%~86%之间不等。共有77例患者完成了治疗并接受了为期3年的随访。在这些患者中，成功率为86%。但如果把所有接受了植入术的患者都计算在内并采用末次观察推进法，那么成功率为79%。如果采用改良后的最坏情况分析，所有没有完成随访的患者都视为治疗失败，那么成功率就只有59%。

 

每周失禁的平均次数从基线的接近10次减至3年结束时的2次左右(77 例患者)。此外，大约40%的患者都达到得了完全控制(100%改善)，还有20%~30%的患者症状改善了75%。

 

在该试验的植入期内，最常见的与装置或与治疗相关的不良事件包括植入部位疼痛(28%的患者)、感觉异常 (15%)、刺激感觉改变 (12%)以及植入部位感染 (10%)。Mellgren博士指出，半数的感染患者必须重新手术，其中5例患者移除了装置。大多数事件只需通过最小干预便可成功解决。

 

包括Mellgren博士在内的3名作者声明接受了美敦力公司提供的研究经费并担任公司顾问。另一名作者为美敦力公司的员工。

 

爱思唯尔  版权所有