Journal article

Publication year: 2010

Pages: 1007-1016

Journal: Diseases of the Colon & Rectum

Volume number: 53

Issue number: 7

ISSN: 0012-3706

eISSN: 1530-0358

Open access status: Bronze

DOI Link: https://doi.org/10.1007/DCR.0b013e3181db7738

Publisher: Lippincott, Williams & Wilkins

Abstract: 

PURPOSE: The efficacy of EMG-biofeedback and low-frequency 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 EMG-biofeedback alone for a 9-month treatment period in a multicenter randomized clinical trial with blinded observers (ClincialTrials.gov 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 EMG-biofeedback (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 amplitude-modulated 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.

Harvard Citation style: Schwandner, T., Koenig, I., Heimerl, T., Kierer, W., Roblick, M., Bouchard, R., et al. (2010) Triple Target Treatment (3T) Is More Effective Than Biofeedback Alone for Anal Incontinence: The 3T-AI Study, Diseases of the Colon and Rectum, 53(7), pp. 1007-1016. https://doi.org/10.1007/DCR.0b013e3181db7738

APA Citation style: Schwandner, T., Koenig, I., Heimerl, T., Kierer, W., Roblick, M., Bouchard, R., Unglaube, T., Holch, P., Ziegler, A., & Kolbert, G. (2010). Triple Target Treatment (3T) Is More Effective Than Biofeedback Alone for Anal Incontinence: The 3T-AI Study. Diseases of the Colon and Rectum. 53(7), 1007-1016. https://doi.org/10.1007/DCR.0b013e3181db7738