NCT00525291

Triple Target Treatment (3T) Which Combines Stimulation With Amplitude Modulated Middle Frequency (AM-MF), Electromyography (EMG)-Triggered Stimulation and EMG-Biofeedback Compared With EMG-Biofeedback in Anal Incontinence

Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation	In the 3T arm, patients were stimulated with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 Hz. Anxious patients trained at first only in the biofeedback mode. The stimulation was introduced after four weeks for these patients. Patients were instructed to carry out the training at home, with an alternating combination in the morning and with EMG-triggered stimulation in the evening, each for 20-minute periods. Apart from this, the protocol of the active treatment group was identical to that of the control group.
DEVICE	EMG-biofeedback alone	In the biofeedback arm, patients were instructed to carry out EMG-biofeedback training at home, standing, mornings and evenings, for 20-minute periods. The core of the task was to pull the plug-electrode upward inside the anal channel, like a lift, and to hold it there during varying periods of tension. This can only be done successfully if the perineum rises and at the same time the puborectal muscle is activated. Just squeezing the sphincter muscles does not produce this lifting effect.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-09-05
• Last updated: 2009-02-18

Locations

1 site across 1 country: Germany