Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004003

Trial Description

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Title

Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback

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Trial Acronym

3T-AI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004003
  •   2012/06/20
  •   2007/09/04
  •   yes
  •   [---]*
  •   83/07, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   NCT00525291  (ClinicalTrials.gov)
  •   83/07 ethics comm. Giessen  (University of Giessen)
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Health Condition or Problem studied

  •   Fecal Incontinence
  •   R15 -  Faecal incontinence
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Interventions/Observational Groups

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

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline; time frame: 9 months after randomization
- 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

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Secondary Outcome

- CCS score after six or three months, compared to baseline; time frame: 3 months, 6 months after randomization
- Adapted Vaizey score after six or three months compared to baseline; time frame: 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; time frame: 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.; time frame: 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.; time frame: 9 months after randomization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/07/31
  •   158
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- All Patients with fecal incontinence I-III.

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Exclusion Criteria

- All Patients with CID´s

- Definite or possible pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Giessen
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    • University of Giessen
    • Thilo Schwandner, Dr. 
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    • University of Giessen
    • Thilo Schwandner, Dr. 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2008/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.