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

NCT ID: NCT00525291

Last Updated: 2009-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 alone

Group Type: ACTIVE_COMPARATOR

EMG-biofeedback alone

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All Patients with fecal incontinence I-III.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Principal Investigators

Thilo Schwandner, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Giessen

Locations

University of Gießen, Dept. of General Surgery

Giessen, Hesse, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21968596 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20551752 (View on PubMed)

Other Identifiers

83/07 ethics comm. Giessen

Identifier Type: -

Identifier Source: org_study_id