Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial.

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).

Medium-term outcome of percutaneous tibial nerve stimulation in the treatment of fecal incontinence.

INTRODUCTION: Fecal incontinence (FI) is a multifactorial disease that affects patients' quality of life. The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTNS) in the treatment of FI and to assess the medium-term results. METHODS: A prospective cohort of patients with FI treated with PTNS between 2012 and 2014 was analysed. Endoluminal ultrasound and anorectal physiologic studies were performed in all patients. The efficacy of PTNS was assessed using a validated questionnaire (Cleveland Clinic Incontinence Score) at baseline, after treatment, and 2 years later. The Vaizey score was also used at 2-year follow-up to assess urge incontinence. RESULTS: Fifty-six patients (38 females; mean age 59.7 years) with FI were treated. The causes of FI were mainly obstetric injury and previous colorectal surgery. A decrease of 50% from baseline CCIS was seen in 41.1% of patients after PTNS. One-third maintained a minimum of 50% decrease of their initial CCIS after 2 years. Comparing CCIS at baseline, after treatment, and at 2-year follow-up, a statistically significant difference was observed (p < 0.0001 and p < 0.0004 respectively). Medium-term improvement was not maintained in patients with passive and mixed FI, while it was maintained in those with urge incontinence. At 2 years, patients with mild incontinence maintained the greatest response. CONCLUSIONS: PTNS is a safe, effective, non-invasive treatment for FI with good results in almost half of the patients at the end of the treatment. There is also an acceptable maintained response at 2-year follow-up. It seems to be most successful in patients with mild incontinence and urge incontinence.