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 .
RCT Entities:
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 .
Authors: Alfonso Javier Ibáñez-Vera; Rosa María Mondéjar-Ros; Vanessa Franco-Bernal; Guadalupe Molina-Torres; Esther Diaz-Mohedo Journal: J Clin Med Date: 2022-09-01 Impact factor: 4.964