Chronic ObstipationPhase 33T-CONCT01672216
Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation
A Phase 3 study testing Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation and EMG-biofeedback alone in people with Chronic Obstipation, run by dr. schwandner at 1 site in Germany.
Trial summary
Previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. The number of randomized controlled trials is low with in part significant systemic deficiencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstipation
- 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
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to May 2015
- 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 chronic obstipation (Rom criteria II)
Who cannot join
- Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes), disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual deficits.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Gießen, Dept. of General Surgery
Giessen, Hesse, 35385
Thilo Schwandner, Dr., 00496419944701, t.schwandner@web.de
About this study
Official title: Triple Target Treatment (3T) Combining Amplitude Modulated Middle Frequency (AM-MF) Stimulation With Electromyography (EMG)EMG-Biofeedback Versus EMG-Biofeedback in Chronic Obstipation
Previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. The number of randomized controlled trials is low with in part significant systemic deficiencies. However, the results from the previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so promising that a further randomized controlled trial appears useful to demonstrate a higher degree of evidence. The purpose of this study is to determine whether triple target treatment (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.
Read the detailed description
Methods in this parallel-group randomized multicenter study with blinded observer we enroll 140 patients with chronic obstipation. The study is divided into two trials. After three months the first trial is completed and can be extended directly into the second trial (completed after 12 months) after an interim analysis. Primary endpoints are changes from baseline to three and twelve months in the Altomare ODS Score.
- Conditions
- Chronic Obstipation
- Being tested
- Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation, EMG-biofeedback alone
- Keywords
- Exercise Therapy, Biofeedback (Psychology), Adult, Chronic Obstipation/*therapy, EMG - Biofeedback, EMG - Triggered Stimulation, Augmented biofeedback
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
EMG-biofeedback aloneDevice
| Study group | Role | What they receive |
|---|---|---|
| Triple Target Treatment | Experimental | 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. Receives: Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation |
| EMG-biofeedback alone | Active comparator | 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. Receives: Device: EMG-biofeedback alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
Measured: 3 months
Secondary outcomes (7)
Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.
Measured: 3 and 12 months
Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline
Measured: 3 and 12 Months
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) after 3 and 12 months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline.
Measured: 3 and 12 months
Hinton Test after 3 and 12 months
Measured: 3 and 12 months
Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline
Measured: 3 and 12 months
Adapted Vaizey score after 3 and 12 months compared to baseline
Measured: 3 and 12 months
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ObstipationStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. schwandner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. schwandner, University of Giessen
- Investigators
- Thilo Schwandner, Dr., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672216
- Sponsor's protocol ID
- 101/12 ethics comm. Giessen
- Acronym
- 3T-CO
- Status last verified
- Sep 2013
- First submitted
- 7 Aug 2012
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwandner T, Hecker A, Hirschburger M, Hecker M, Kierer W, Padberg W. Does the STARR procedure change the pelvic floor: a preoperative and postoperative study with dynamic pelvic floor MRI. Dis Colon Rectum. 2011 Apr;54(4):412-7. doi: 10.1007/DCR.0b013e318205ddda.
PubMed 21383560
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Target Treatment (3T) Combining Amplitude Modulated Middle Frequency (AM-MF) Stimulation With Electromyography (EMG)EMG-Biofeedback Versus EMG-Biofeedback in Chronic Obstipation
- ClinicalTrials.gov ID
- NCT01672216
- Acronym / sponsor ID
- 3T-CO / 101/12 ethics comm. Giessen
- Conditions
- Chronic Obstipation
- Keywords
- Exercise Therapy, Biofeedback (Psychology), Adult, Chronic Obstipation/*therapy, EMG - Biofeedback, EMG - Triggered Stimulation, Augmented biofeedback
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- dr. schwandnerUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Aug 2012 (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.
Previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. The number of randomized controlled trials is low with in part significant systemic deficiencies. However, the results from the previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so promising that a further randomized controlled trial appears useful to demonstrate a higher degree of evidence. The purpose of this study is to determine whether triple target treatment (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.
Detailed description
Methods in this parallel-group randomized multicenter study with blinded observer we enroll 140 patients with chronic obstipation. The study is divided into two trials. After three months the first trial is completed and can be extended directly into the second trial (completed after 12 months) after an interim analysis. Primary endpoints are changes from baseline to three and twelve months in the Altomare ODS Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Target Treatment | Experimental | Device: 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. |
| EMG-biofeedback alone | Active comparator | Device: 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. |
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 chronic obstipation (Rom criteria II)
Key exclusion criteria (1 listed)
- Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes), disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual deficits.
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-stimulation | Device | Triple Target Treatment |
| EMG-biofeedback alone | Device | EMG-biofeedback alone |
Primary outcome
Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
Time frame: 3 months
7 secondary outcomes
Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.
Time frame: 3 and 12 months
Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline
Time frame: 3 and 12 Months
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) after 3 and 12 months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline.
Time frame: 3 and 12 months
Hinton Test after 3 and 12 months
Time frame: 3 and 12 months
Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline
Time frame: 3 and 12 months
Adapted Vaizey score after 3 and 12 months compared to baseline
Time frame: 3 and 12 months
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline.
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Background: PubMed 21383560Schwandner T, Hecker A, Hirschburger M, Hecker M, Kierer W, Padberg W. Does the STARR procedure change the pelvic floor: a preoperative and postoperative study with dynamic pelvic floor MRI. Dis Colon Rectum. 2011 Apr;54(4):412-7. doi: 10.1007/DCR.0b013e318205ddda.
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 Chronic Obstipation, run by dr. schwandner 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 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thilo Schwandner, Dr. (00496419944701, t.schwandner@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline. (time frame: 3 months). 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 NCT01672216, which also lists 1 linked publication.
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 23 Sep 2013.