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

Abstract

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).

Efficacy of Tibial Nerve Stimulation on Fecal Incontinence in Patients With Low Anterior Resection Syndrome Following Surgery for Colorectal Cancer

“…With regard to the outcome measures, the LARS score [ 21 ] was adopted to assess the bowel function after anterior rectal resection for colorectal cancer in all the included studies. Additionally, to assess the frequency, type, and severity of fecal incontinence, the obstructed defecation syndrome (ODS) score [ 22 ] was employed in three studies [ 17 , 19 , 20 ], the St. Mark Fecal Incontinence score [ 23 ] was used in two studies [ 18 , 20 ], and the Wexner score [ 24 ] and the Fecal Incontinence Severity Index (FISI) [ 25 ] were adopted in one study each [ 16 , 19 ]. The impact of fecal incontinence on the patient quality of life was evaluated using the Fecal Incontinence Quality of Life (FIQL) score in three studies [ 16 , 19 , 20 ] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [ 26 ] in three other studies [ 17 - 19 ].…”

“…Enriquez-Navascues et al [17] reported that although LARS scores significantly decreased in both the intervention and control groups, the number of patients transferred from the "major LARS" category to the "no LARS" category was higher in the control group (eight out of 10 patients) than in the intervention group (three out of 13 patients). In two other studies [18,19], the LARS score…”

“…The included studies were published between 2017 and 2021 and were conducted in Spain [16][17][18] and Italy [19], while one study was multi-centered [20]. Regarding the study design, two of the included studies were prospective non-randomized studies [16,20], and three studies were RCTs [17][18][19].…”

“…The included studies were published between 2017 and 2021 and were conducted in Spain [16][17][18] and Italy [19], while one study was multi-centered [20]. Regarding the study design, two of the included studies were prospective non-randomized studies [16,20], and three studies were RCTs [17][18][19]. All included studies employed www.e-arm.org an identical tibial nerve stimulation technique in which a needle was placed at the percutaneous or posterior tibial nerve without anesthesia; additionally, the stimulation parameters were set to a 200 μs pulse width and a frequency of 20 Hz.…”

“…One study was open [17], whereas single-blinding [19] and double-blinding [18] were adopted in a single trial. Tibial nerve stimulation was administered during 20 sessions [17], 17 sessions [19], and 16 sessions [18] of 30 minutes of stimulation each, with follow-up periods of 6 months [17] and 12 months [18,19], respectively.…”