Randomized Pilot Study Anal Inserts Versus Percutaneous Tibial Nerve Stimulation In Patients With Fecal Incontinence.

BACKGROUND Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence who have failed other conservative treatments. OBJECTIVE We aimed to compare anal inserts and percutaneous tibial nerve stimulation. DESIGN This was an investigator blinded randomized pilot study. SETTINGS The study was conducted at a large tertiary care hospital. PATIENTS Adult patients with passive or mixed fecal incontinence were recruited. INTERVENTIONS Patients were randomized to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of three months. MAIN OUTCOME MEASURES The primary endpoint was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed two-week bowel diary. Secondary endpoints were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel (ICIQ-B) scores (for bowel pattern, bowel control and quality of life) use of antidiarrheal agents, estimates of comfort and acceptability. RESULTS Fifty patients were recruited: 25 were randomized to anal inserts and 25 to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the two-week bowel diary, the St Mark's score and the ICIQ-B scores was seen in both groups after 3 months of treatment. A reduction of ≥ 50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared to 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's Fecal incontinence scores, ICIQ-B scores for bowel pattern, bowel control and quality of life (p = 0.01) suggest similar improvement for each group. LIMITATIONS A realistic sample size calculation could not be performed due to paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation. CONCLUSIONS Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460 .