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 (3T-AI)

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).

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation; Device: EMG-biofeedback alone

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Gießen, Hesse, Germany, 35385
      • University of Gießen, Dept. of General Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All Patients with fecal incontinence I-III.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMG-biofeedback plus EMG-triggered AM-MF-stimulation	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.
Active Comparator: EMG-biofeedback alone	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Thilo Schwandner, Dr., University of Gießen

Publications and helpful links

General Publications

• Schwandner T, Heimerl T, Konig IR, Kierer W, Roblick M, Bouchard R, Unglaube T, Holch P, Kolbert G, Padberg W, Ziegler A. [3T-AI: a new treatment algorithm for anal incontinence with a higher evidence level]. Zentralbl Chir. 2012 Aug;137(4):345-51. doi: 10.1055/s-0031-1271468. Epub 2011 Sep 27. German.
• Schwandner T, Konig IR, Heimerl T, Kierer W, Roblick M, Bouchard R, Unglaube T, Holch P, Ziegler A, Kolbert G. Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study. Dis Colon Rectum. 2010 Jul;53(7):1007-16. doi: 10.1007/DCR.0b013e3181db7738. Erratum In: Dis Colon Rectum. 2011 Nov;54(11):1461.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 4, 2007
• First Submitted That Met QC Criteria: September 4, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2009
• Last Update Submitted That Met QC Criteria: February 17, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Adult; Exercise Therapy; Biofeedback (Psychology); Fecal Incontinence/*therapy; EMG - Biofeedback; EMG - Triggered Stimulation; Augmented biofeedback
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 83/07 ethics comm. Giessen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No