BACKGROUND Treatment of low anterior resection syndrome (LARS) is challenging. Percutaneous tibial nerve stimulation (PTNS) can improve select bowel disorders. An RCT was conducted to assess the efficacy of PTNS compared with sham stimulation in patients with severe LARS. METHOD This was a multicentre, double-blind RCT. Patients with major LARS score were allocated to receive PTNS or sham therapy (needle placement simulation without nerve stimulation). The study included 16 sessions of 30 min once a week for 12 consecutive weeks, followed by four additional sessions once a fortnight for the following 4 weeks. The primary endpoint was efficacy of PTNS defined by the LARS score 12 months after treatment. Secondary endpoints included faecal incontinence, quality of life (QoL), and sexual function. RESULTS Between September 2016 and July 2018, 46 eligible patients were assigned randomly in a 1 : 1 ratio to PTNS or sham therapy. Baseline characteristics were similar. LARS scores were reduced in both groups, but only patients who received PTNS maintained the effect in the long term (mean(s.d.) score 36.4(3.9) at baseline versus 30.7(11.5) at 12 months; P = 0.018; effect size -5.4, 95 per cent c.i. -9.8 to -1.0), with a mean reduction of 15.7 per cent at 12-month follow-up. The faecal incontinence score was improved after 12 months in the PTNS group (mean(s.d.) score 15.4(5.2) at baseline versus 12.5(6.4) at 12 months; P = 0.018). No major changes in QoL and sexual function were observed in either group. There was no therapy-associated morbidity. Three patients discontinued the study, but none owing to study-related issues. CONCLUSION PTNS has positive effects in some patients with major LARS, especially in those with faecal incontinence. Registration number: NCT02517853 (http://www.clinicaltrials.gov).

中文翻译：

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严重低位前切除综合征患者的经皮胫骨神经刺激：随机临床试验。

背景技术低位前切除综合征（LARS）的治疗具有挑战性。经皮胫神经刺激（PTNS）可以改善某些肠道疾病。进行了RCT，以评估PTNS与重度LARS患者进行假刺激相比的疗效。方法这是一个多中心，双盲RCT。LARS得分高的患者被分配接受PTNS或假手术治疗（模拟无神经刺激的针头放置）。该研究包括连续12周，每周一次，每次30分钟的16个疗程，然后在接下来的4周中，每两周两次进行另外四个疗程。主要终点是治疗后12个月的LARS评分定义的PTNS的疗效。次要终点包括大便失禁，生活质量（QoL）和性功能。结果在2016年9月至2018年7月之间，将46例符合条件的患者以1：1的比例随机分配给PTNS或假疗法。基线特征相似。两组的LARS得分均降低，但是只有接受PTNS的患者才能长期保持效果（基线时的平均（sd）得分为36.4（3.9），而12个月时为30.7（11.5）； P = 0.018；效果大小为-5.4 ，95％ci -9.8至-1.0），在12个月的随访中平均下降了15.7％。PTNS组在12个月后粪便失禁评分得到了改善（基线时的平均（sd）评分为15.4（5.2），而12个月时的平均值为12.5（6.4）； P = 0.018）。两组均未观察到QoL和性功能的重大变化。没有与治疗相关的发病率。三名患者中止了研究，但没有因研究相关问题而中止。结论PTNS在一些大的LARS患者中具有积极的作用，尤其是在大便失禁的患者中。注册号：NCT02517853（http://www.clinicaltrials.gov）。