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)

This study has been completed.
Sponsor:
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00525291
First received: September 4, 2007
Last updated: February 17, 2009
Last verified: January 2009
  Purpose

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).


Condition Intervention Phase
Fecal Incontinence
Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation
Device: EMG-biofeedback alone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline [ Time Frame: 9 months after randomization ] [ Designated as safety issue: No ]
  • Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CCS score after six or three months, compared to baseline [ Time Frame: 3 months, 6 months after randomization ] [ Designated as safety issue: No ]
  • Adapted Vaizey score after six or three months compared to baseline [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 9 months after randomization ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Patients with fecal incontinence I-III.

Exclusion Criteria:

  • All Patients with CID´s
  • Definite or possible pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525291

Locations
Germany
University of Gießen, Dept. of General Surgery
Gießen, Hesse, Germany, 35385
Sponsors and Collaborators
University of Giessen
Investigators
Principal Investigator: Thilo Schwandner, Dr. University of Giessen
  More Information

No publications provided by University of Giessen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Gießen und Marburg, Standort Gießen
ClinicalTrials.gov Identifier: NCT00525291     History of Changes
Other Study ID Numbers: 83/07 ethics comm. Giessen
Study First Received: September 4, 2007
Last Updated: February 17, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Exercise Therapy
Biofeedback (Psychology)
Adult
Fecal Incontinence/*therapy
EMG - Biofeedback
EMG - Triggered Stimulation
Augmented biofeedback

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014