Fecal IncontinencePhase 33T-AINCT00525291
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
A Phase 3 study testing Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation and EMG-biofeedback alone in people with Fecal Incontinence, run by University of Giessen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation and EMG-biofeedback alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients with fecal incontinence I-III.
Who cannot join
- All Patients with CID´s
- Definite or possible pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Gießen, Dept. of General Surgery
Giessen, Hesse, 35385
About this study
Official title: Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback
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
- Being tested
- Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation, EMG-biofeedback alone
- Keywords
- Exercise Therapy, Biofeedback (Psychology), Adult, Fecal Incontinence/*therapy, EMG - Biofeedback, EMG - Triggered Stimulation, Augmented biofeedback
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulationDevice
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 aloneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EMG-biofeedback plus EMG-triggered AM-MF-stimulation | Experimental | Not described Receives: Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation |
| EMG-biofeedback alone | Active comparator | Not described Receives: Device: EMG-biofeedback alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline
Measured: 9 months after randomization
Validated new St. Mark's incontinence score (Vaizey score) in its adapted German form after nine months, compared to baseline.
Measured: 9 months after randomization
Secondary outcomes (5)
CCS score after six or three months, compared to baseline
Measured: 3 months, 6 months after randomization
Adapted Vaizey score after six or three months compared to baseline
Measured: 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
Measured: 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.
Measured: 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.
Measured: 9 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Investigators
- Thilo Schwandner, Dr., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525291
- Sponsor's protocol ID
- 83/07 ethics comm. Giessen
- Acronym
- 3T-AI
- Status last verified
- Jan 2009
- First submitted
- 4 Sep 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21968596Schwandner 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.
PubMed 20551752
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Multicenter Study to Assess the Outcome of Conservative 3T Treatment With EMG-Biofeedback
- ClinicalTrials.gov ID
- NCT00525291
- Acronym / sponsor ID
- 3T-AI / 83/07 ethics comm. Giessen
- Conditions
- Fecal Incontinence
- Keywords
- Exercise Therapy, Biofeedback (Psychology), Adult, Fecal Incontinence/*therapy, EMG - Biofeedback, EMG - Triggered Stimulation, Augmented biofeedback
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Patients with fecal incontinence I-III.
Key exclusion criteria (2 listed)
- All Patients with CID´s
- Definite or possible pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulationIn 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. | Device | EMG-biofeedback plus EMG-triggered AM-MF-stimulation |
| EMG-biofeedback aloneIn 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. | Device | EMG-biofeedback alone |
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Derived from this study: PubMed 21968596Schwandner 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.
- Derived from this study: PubMed 20551752Schwandner 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.
Related trials for Fecal Incontinence
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
Active, not recruitingPhase 2/3
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thilo Schwandner, Dr. principal investigator
University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation and EMG-biofeedback alone in people with Fecal Incontinence, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleveland Clinic Incontinence Score (CCS) in its validated German form after nine months, compared to baseline (time frame: 9 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.