Tjandra Joe J, Chan Miranda K Y, Yeh Chung Hung, Murray-Green Carolyn
Department of Colorectal Surgery, Epworth Hospital, University of Melbourne, Melbourne, Australia.
Dis Colon Rectum. 2008 May;51(5):494-502. doi: 10.1007/s10350-007-9103-5. Epub 2008 Feb 16.
This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence.
Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months.
The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of < or = 120 degrees of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 "successful" patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group.
Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy.
本随机研究旨在比较骶神经调节与最佳药物治疗对严重大便失禁患者的疗效。
将严重大便失禁患者（年龄39 - 86岁）随机分为接受骶神经刺激组（SNS组；n = 60）或最佳支持治疗组（对照组；n = 60），最佳支持治疗包括盆底肌锻炼、填充剂和饮食调整。全面评估包括肛管超声、肛肠生理学、为期两周的排便日记以及大便失禁生活质量指数。随访期为12个月。
骶神经刺激组与对照组在性别（女性:男性 = 11:1 对比 14:1）和年龄（平均63.9岁对比63岁）方面相似。两组间肛门外括约肌≤120度缺陷和阴部神经病变的发生率相似。试验筛查使54例患者（90%）的失禁发作减少超过50%。在这54例“成功”患者中的53例进行了全阶段骶神经刺激。无感染并发症。通过骶神经刺激，每周平均失禁发作次数从9.5次降至3.1次（P < 0.0001），每周平均失禁天数从3.3天降至1天（P < 0.0001）。25例患者（47.2%）实现了完全控便。在骶神经刺激组，四个领域的大便失禁生活质量指数均有显著改善（P < 0.0001）。相比之下，对照组的大便失禁及大便失禁生活质量评分无显著改善。
与接受最佳药物治疗的对照组相比，骶神经调节显著改善了严重大便失禁患者的治疗效果。
