Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: The 3T-AI study

Thilo Schwandner, Inke R. König, Tankred Heimerl, Walter Kierer, Michael Roblick, Ralf Bouchard, Thorsten Unglaube, Philipp Holch, Andreas Ziegler*, Gerd Kolbert

*Corresponding author for this work
45 Citations (Scopus)


PURPOSE: The efficacy of EMG-biofeedback and lowfrequency electrical stimulation for the treatment of anal incontinence has not been proven. Our purpose was to evaluate a novel therapeutic concept, termed triple target treatment, which combines amplitude-modulated medium-frequency stimulation and EMG-biofeedback. METHODS: Patients with anal incontinence were randomly assigned to the triple target regimen or EMGbiofeedback alone for a 9-month treatment period in a multicenter randomized clinical trial with blinded observers ( registration number NCT00525291). Primary end points were changes in the Cleveland Clinic score and the adapted St. Mark's (Vaizey) score at 9 months compared with baseline. Secondary end points included therapy acceptance and proportion of patients achieving continence or improvement in grade or frequency of incontinence. RESULTS: We enrolled 158 patients with anal incontinence. The median decrease in the Cleveland Clinic score from baseline to 9 months was 3 points greater for the triple target regimen than for EMGbiofeedback (95% CI, 1-4; P = .0024). The improvement was 8 points for the triple target regimen (95% CI, 7-9) and 5 points for EMG-biofeedback (95% CI, 4-7). Results were similar for the Vaizey score. Of patients treated for at least 3 months, continence was achieved by 50% of patients with the triple target regimen and 25.8% of those with EMG-biofeedback. CONCLUSIONS: The combination of amplitudemodulated medium-frequency electrostimulation with EMG-biofeedback in the triple target regimen is superior to EMG-biofeedback alone in the treatment of anal incontinence. Therapy programs for fecal incontinence are most effective if patients participate for longer than 2 to 3 months.

Original languageEnglish
JournalDiseases of the Colon and Rectum
Issue number7
Pages (from-to)1007-1016
Number of pages10
Publication statusPublished - 01.07.2010


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