Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in faecal incontinence

Abstract

Abstract Background Percutaneous, transcutaneous and sham transcutaneous posterior tibial nerve stimulation was compared in a prospective blinded randomized placebo-controlled trial. Methods Patients who had failed conservative treatment for faecal incontinence were randomized to one of three groups: group 1, percutaneous; group 2, transcutaneous; group 3, sham transcutaneous. Patients in groups 1 and 2 received 30-min sessions of posterior tibial nerve stimulation twice weekly for 6 weeks. In group 3, transcutaneous electrodes were placed in position but no stimulation was delivered. Symptoms were measured at baseline and after 6 weeks using a bowel habit diary and St Mark's continence score. Response to treatment was defined as a reduction of at least 50 per cent in weekly episodes of faecal incontinence compared with baseline. Results Thirty patients (28 women) were enrolled. Nine of 11 patients in group 1, five of 11 in group 2 and one of eight in group 3 had a reduction of at least 50 per cent in weekly episodes of faecal incontinence at the end of the 6-week study phase (P = 0·035). Patients undergoing percutaneous nerve stimulation had a greater reduction in the number of incontinence episodes and were able to defer defaecation for a longer interval than those undergoing transcutaneous and sham stimulation. These improvements were maintained over a 6-month follow-up period. Conclusion Posterior tibial nerve stimulation has short-term benefits in treating faecal incontinence. Percutaneous therapy appears to have superior efficacy to stimulation applied by the transcutaneous route. Registration number: NCT00530933 (http://www.clinicaltrials.gov).