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).