Clinical trial NCT00525291: 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
Official title: Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fecal Incontinence
Keywords: Exercise Therapy
Biofeedback (Psychology)
Adult
Fecal Incontinence/*therapy
EMG - Biofeedback
EMG - Triggered Stimulation
Augmented biofeedback
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* All Patients with fecal incontinence I-III.

Exclusion Criteria:

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

Primary outcomes:
measure: Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline
timeFrame: 9 months after randomization
measure: Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline.
timeFrame: 9 months after randomization
Secondary outcomes:
measure: CCS score after six or three months, compared to baseline
timeFrame: 3 months, 6 months after randomization
measure: Adapted Vaizey score after six or three months compared to baseline
timeFrame: 3 months, 6 months
measure: 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
timeFrame: 9 months after randomization
measure: 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.
timeFrame: 9 months after randomization
measure: 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.
timeFrame: 9 months after randomization
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Gießen, Dept. of General Surgery
state: Hesse
Study officials:
affiliation: University of Giessen
name: Thilo Schwandner, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.