Transcutaneous electrical tibial nerve stimulation in the treatment of fecal incontinence: a randomized trial (CONSORT 1a).

OBJECTIVES: The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat fecal incontinence (FI), its efficacy has never been proved using controlled trials. METHODS: In this randomized, double-blind, sham-controlled trial, 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events. RESULTS: No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47%) who received the active TENS treatment exhibited a >30% decrease in the FI severity score compared with 19 patients (27%) who received the sham treatment (odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (P=0.01). One minor therapy-related adverse event was observed (1.5%) (see Supplementary Consort 1b). CONCLUSIONS: We failed to demonstrate any benefit of TENS on our primary end-point.

Predictive factors for successful sacral nerve stimulation in the treatment of faecal incontinence: results of trial stimulation in 200 patients.

AIM: Sacral nerve stimulation (SNS) has a place in the treatment algorithm for faecal incontinence (FI). However, after implantation, 15-30% of patients with FI fail to respond for unknown reasons. We investigated the effect of SNS on continence and quality of life (QOL) and tried to identify specific predictive factors of the success of permanent SNS in the treatment of FI. METHOD: Two hundred consecutive patients (six men; median age = 60; range 16-81) underwent permanent implantation for FI. The severity of FI was evaluated by the Cleveland Clinic Score. Quality of life was evaluated by the French version of the American Society of Colon and Rectal Surgeons (ASCRS) quality of life questionnaire (FIQL). All patients underwent a preoperative evaluation. After permanent implantation, severity and QOL scores were reevaluated after six and 12 months and then once a year. RESULTS: The severity scores were significantly reduced during SNS (P = 0.001). QOL improved in all domains. At the 6-month follow-up, the clinical outcome of the permanent implant was not affected by age, gender, duration of symptoms, QOL, main causes of FI, anorectal manometry or endoanal ultrasound results. Only loose stool consistency (P = 0.01), persistent FI even though diarrhoea was controlled by medical treatment (P = 0.004), and low stimulation intensity (P = 0.02) were associated with improved short-term outcomes. Multivariate analysis confirmed that loose stool consistency and low stimulation intensity were related to a favourable outcome. CONCLUSION: Stool consistency and low stimulation intensity have been identified as predictive factors for the short-term outcome of SNS.

Does magnetic stimulation of sacral nerve roots modify colonic motility? Results of a randomized double-blind sham-controlled study.

Although sacral nerve root stimulation (SNS) can result in a symptomatic improvement of faecal incontinence, the mechanism of action remains unknown. The aim of this study was to assess whether short-term magnetic SNS can inhibit pharmacologically induced propulsive colonic contractions. Twelve healthy volunteers (median age: 43.5 years old) were studied on two separate occasions and randomized into either active (15 Hz, 100% output intensity for 5 s min(-1) for 30 min) or sham rapid rate lumbosacral magnetic stimulation (rLSMS). Colorectal motility was recorded with a manometric catheter located at the most proximal transducer in the left colon and the most distal, in the rectum. Colonic contractions were provoked by instilling Bisacodyl. The effects of rLSMS on colonic, sigmoid and rectal contractions were monitored and recorded after Bisacodyl instillation. The appearance of high-amplitude contractions propagated or not (HAC/HAPC) provoked by Bisacodyl instillation was significantly delayed during active compared to sham stimulation (P = 0.03). There was no difference in the characteristics of HAC/HAPC (i.e. frequency, amplitude, duration, velocity of propagation) or the motility index with active or sham stimulation. The perception of urgency tended to be decreased with rLSMS following Bisacodyl instillation. The catheter was expulsed within a median of 16.5 min (range 8-39) after Bisacodyl administration during active stimulation compared to 14 min (range 5-40) during sham stimulation (P = 0.03). This study suggests that rLSMS could delay the appearance of the first Bisacodyl-induced colonic contractions.