Fecal Incontinence Clinical Trial
Official title:
Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback
The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of
anal incontinence has not been proven. First, large well-designed clinical trials are
missing. Second, only few patients reach therapeutically relevant intensities with low
frequency stimulation. In this study, a novel therapeutic concept, termed triple target
treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle
frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was
compared with EMG-biofeedback alone after a nine month treatment period.
Methods In this parallel-group randomised multicenter study with blinded observer we
enrolled 158 patients with anal incontinence. Primary endpoints were changes from baseline
to nine months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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