<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672216</url>
  </required_header>
  <id_info>
    <org_study_id>101/12 ethics comm. Giessen</org_study_id>
    <nct_id>NCT01672216</nct_id>
  </id_info>
  <brief_title>Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation</brief_title>
  <acronym>3T-CO</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>dr. schwandner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies revealed only a low evidence for the various biofeedback methods and pelvic&#xD;
      floor exercises for treatment of chronic obstipation. The number of randomized controlled&#xD;
      trials is low with in part significant systemic deficiencies. However, the results from the&#xD;
      previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so&#xD;
      promising that a further randomized controlled trial appears useful to demonstrate a higher&#xD;
      degree of evidence. The purpose of this study is to determine whether triple target treatment&#xD;
      (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if&#xD;
      the duration of treatment (3, 6 or 9 months) influence the efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods in this parallel-group randomized multicenter study with blinded observer we enroll&#xD;
      140 patients with chronic obstipation. The study is divided into two trials. After three&#xD;
      months the first trial is completed and can be extended directly into the second trial&#xD;
      (completed after 12 months) after an interim analysis. Primary endpoints are changes from&#xD;
      baseline to three and twelve months in the Altomare ODS Score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline</measure>
    <time_frame>3 and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hinton Test after 3 and 12 months</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Vaizey score after 3 and 12 months compared to baseline</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline.</measure>
    <time_frame>3 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Chronic Obstipation</condition>
  <arm_group>
    <arm_group_label>Triple Target Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMG-biofeedback alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation</intervention_name>
    <arm_group_label>Triple Target Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EMG-biofeedback alone</intervention_name>
    <arm_group_label>EMG-biofeedback alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Patients with chronic obstipation (Rom criteria II)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes),&#xD;
             disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy&#xD;
             desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual&#xD;
             deficits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thilo Schwandner, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Giessen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thilo Schwandner, Dr.</last_name>
    <phone>00496419944701</phone>
    <email>t.schwandner@web.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Gießen, Dept. of General Surgery</name>
      <address>
        <city>Gießen</city>
        <state>Hessen</state>
        <zip>35385</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thilo Schwandner, Dr.</last_name>
      <phone>00496419944701</phone>
      <email>t.schwandner@web.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21383560</PMID>
  </reference>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>September 20, 2013</last_update_submitted>
  <last_update_submitted_qc>September 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Giessen</investigator_affiliation>
    <investigator_full_name>dr. schwandner</investigator_full_name>
    <investigator_title>Head of Coloproctology</investigator_title>
  </responsible_party>
  <keyword>Exercise Therapy</keyword>
  <keyword>Biofeedback (Psychology)</keyword>
  <keyword>Adult</keyword>
  <keyword>Chronic Obstipation/*therapy</keyword>
  <keyword>EMG - Biofeedback</keyword>
  <keyword>EMG - Triggered Stimulation</keyword>
  <keyword>Augmented biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672216
org study id: 101/12 ethics comm. Giessen
nct id: NCT01672216
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
time frame: 3 months
measure: Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.
time frame: 3 and 12 months
measure: Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline
time frame: 3 and 12 Months
measure: 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
measure: Hinton Test after 3 and 12 months
time frame: 3 and 12 months
measure: Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline
time frame: 3 and 12 months
measure: Adapted Vaizey score after 3 and 12 months compared to baseline
time frame: 3 and 12 months
measure: 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
arm group label: Triple Target Treatment
arm group type: Experimental
description: 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.
arm group label: EMG-biofeedback alone
arm group type: Active Comparator
description: 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
intervention name: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation
arm group label: Triple Target Treatment
intervention type: Device
intervention name: EMG-biofeedback alone
arm group label: EMG-biofeedback alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thilo Schwandner, Dr.
role: Principal Investigator
affiliation: University of Giessen
last name: Thilo Schwandner, Dr.
phone: 00496419944701
email: t.schwandner@web.de
facility: 
status: Recruiting
contact: 
country: Germany
citation: 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.
PMID: 21383560
responsible party type: Sponsor-Investigator
investigator affiliation: University of Giessen
investigator full name: dr. schwandner
investigator title: Head of Coloproctology
mesh term: Constipation