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

Fecal Incontinence Clinical Trial

— 3T-AI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525291
• Other study ID #: 83/07 ethics comm. Giessen
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2007
• Last updated: February 17, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All Patients with fecal incontinence I-III.

Exclusion Criteria:

• All Patients with CID´s

• Definite or possible pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University of Gießen, Dept. of General Surgery	Gießen	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline		9 months after randomization	No
Primary	Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline.		9 months after randomization	No
Secondary	CCS score after six or three months, compared to baseline		3 months, 6 months after randomization	No
Secondary	Adapted Vaizey score after six or three months compared to baseline		3 months, 6 months	No
Secondary	Quality of life according to the Fecal Incontinence Quality of Life Scale (FIQoL) in its validated German form after nine months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline		9 months after randomization	No
Secondary	Track record of the treatment: 1. Continent, 2. Grade improvement (grade II or III to grade I), 3. Frequency improvement: (same grade, >= 2 points improvement in CCS), 4. no improvement, or deterioration, 5. early dropouts.		9 months after randomization	No
Secondary	Use of stool regulating medication. Specifically, if biofeedback and 3T increase continence, the use of any stool regulating medication (Fleawort seeds, Loperamide, teas, etc.) should decrease in the course of the trial.		9 months after randomization	No