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

Phase 3

Completed

• Conditions: Fecal Incontinence
• Interventions: Device: EMG-biofeedback alone; Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation

• Registration Number: NCT00525291
• Lead Sponsor: University of Giessen

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• All Patients with fecal incontinence I-III.

Exclusion Criteria

• All Patients with CID´s
• Definite or possible pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG-biofeedback alone	EMG-biofeedback alone	-
EMG-biofeedback plus EMG-triggered AM-MF-stimulation	Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation	-

Primary Outcome Measures

Name	Time	Method
Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline	9 months after randomization
Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline.	9 months after randomization

Secondary Outcome Measures

Name	Time	Method
CCS score after six or three months, compared to baseline	3 months, 6 months after randomization
Adapted Vaizey score after six or three months compared to baseline	3 months, 6 months
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
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
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

Trial Locations

Locations (1)

University of Gießen, Dept. of General Surgery; 🇩🇪 Gießen, Hesse, Germany