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

NCT00525291 | Completed Phase 3 DMC

• 1 other identifier: 83/07 ethics comm. Giessen
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Fecal Incontinence

Keywords

Exercise Therapy; Biofeedback (Psychology); Adult; Fecal Incontinence/*therapy; EMG - Biofeedback; EMG - Triggered Stimulation; Augmented biofeedback

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

EMG-biofeedback plus EMG-triggered AM-MF-stimulation

EXPERIMENTAL

Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation

EMG-biofeedback alone

ACTIVE COMPARATOR

Device: EMG-biofeedback alone

Interventions

Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation DEVICE

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 plus EMG-triggered AM-MF-stimulation

EMG-biofeedback alone DEVICE

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.

EMG-biofeedback alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients with fecal incontinence I-III.

You may not qualify if:

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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University of Gießen, Dept. of General Surgery

Giessen, Hesse, 35385, Germany

Location

Related Publications (2)

• 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.

  PMID: 21968596 DERIVED

• 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.

  PMID: 20551752 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Thilo Schwandner, Dr.

  University of Giessen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 18, 2009

Record last verified: 2009-01

Locations

DE (1)