<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/NCT02263170</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-BE: 048/2014</org_study_id>
    <nct_id>NCT02263170</nct_id>
  </id_info>
  <brief_title>Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study</brief_title>
  <official_title>Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nano-Tera.ch, Lausanne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spitäler Schaffhausen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary&#xD;
      consortium consisting of representatives ranging from clinical medicine via microelectronics&#xD;
      towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The&#xD;
      aim of this campaign includes development of implantable prototype devices acting as&#xD;
      artificial continence muscles using low-voltage electrically activated polymers (EAPs)&#xD;
      controlled by implemented pressure sensors and the patient.&#xD;
&#xD;
      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal&#xD;
      sphincter complex are of cardinal importance. Most of the existing data on anatomy and&#xD;
      physiology results is based on old studies and almost no data on biomechanical properties are&#xD;
      available. However, new technologies or even merging data from different examination methods&#xD;
      might provide new information in this field.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Fecal incontinence (FI) is affecting self-confidence and can lead to social isolation and&#xD;
      even loss of employment Often conservative treatment as the first option is ineffective and&#xD;
      surgical interventions follow conservative are necessary.&#xD;
&#xD;
      Small defects of the anal sphincter muscles might be treated with sphincter repair and sacral&#xD;
      neuromodulation (SNM) However, patients rarely become fully continent or short-term results&#xD;
      deteriorate in the long term [1]. Those patients and patients with large defects are&#xD;
      candidates for a neosphincter procedure (artificial bowel sphincter or graciloplasty).&#xD;
      However, the success rate of these methods is limited and the explantation rate is high. A&#xD;
      permanent colostomy associated with massive psychosocial impairment remains as ultimate&#xD;
      treatment option With the project Smart Muscle for Incontinence Treatment (SMIT) a&#xD;
      multidisciplinary consortium consisting of representatives ranging from clinical medicine via&#xD;
      microelectronics towards biomaterial science aims to develop a novel implant to treat faecal&#xD;
      incontinence. The aim of this campaign includes development of implantable prototype devices&#xD;
      acting as artificial continence muscles using low-voltage electrically activated polymers&#xD;
      (EAPs) controlled by implemented pressure sensors and the patient.&#xD;
&#xD;
      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal&#xD;
      sphincter complex are of cardinal importance. Most of the existing data on anatomy and&#xD;
      physiology results is based on old studies and almost no data on biomechanical properties are&#xD;
      available. However, new technologies or even merging data from different examination methods&#xD;
      might provide new information in this field.&#xD;
&#xD;
      Accurate imaging data on the pelvic floor region is crucial for the development of a new,&#xD;
      implantable device for restoration of fecal continence. Optimal size (inner, outer diameter,&#xD;
      length) and geometrical shape (cylinder, cone, torus) adapted to different functional states&#xD;
      (rest, squeezing, defecation) will improve function and prevent erosion and consequent&#xD;
      infection of such a prosthesis.&#xD;
&#xD;
      With this study, the investigators aim to correlate three-dimensional endoanal&#xD;
      ultrasonographic images with MRI images. The combination of different imaging techniques has&#xD;
      been demonstrated to eliminate individual drawbacks of the examination methods and therefore&#xD;
      would allow a precise description of the tissue [2]. The registered data with their&#xD;
      complementary information would permit the distinct segmentation and three-dimensional&#xD;
      presentations of the anatomical structures in the pelvic area. This information has a great&#xD;
      potential to facilitate diagnostics and surgical planning in this region.&#xD;
&#xD;
      High-resolution anal manometry (HRAM) provides intra-anal pressure during rest or maximum&#xD;
      pressure with high spatial and time resolution.&#xD;
&#xD;
      However Biomechanical properties of the anal canal as elasticity or stiffness (compliance or&#xD;
      flexibility) of the tissue representing important parameters for a continence organ are not&#xD;
      routinely evaluated in daily clinical practice. Functional Lumen Imaging Probe (FLIP) allows&#xD;
      the measurement of a cross sectional area (CSA) with respect to applied luminal pressure,&#xD;
      respectively. FLIP has the potential to be useful in order to assess the biomechanical&#xD;
      properties of the sphincter region. Such information potentially gives new insights in&#xD;
      physiology and pathophysiology of the continence process.&#xD;
&#xD;
      With this pilot study, the investigators aim to acquire anatomical and biomechanical data&#xD;
      using established (manometry) and novel technologies (merging endoanal ultrasound and MRI&#xD;
      data) in 20 healthy probands (10 male, 10 female).&#xD;
&#xD;
      Objective&#xD;
&#xD;
      Primary objective is to collect anatomical, physiological and biomechanical characteristics&#xD;
      of the continence organ (sphincters and pelvic floor) in order to specify properties of a new&#xD;
      implant for the treatment of faecal incontinence.&#xD;
&#xD;
      Secondary objectives are: test feasibility of FLIP in measuring the biomechanical properties&#xD;
      of the anal canal and test feasibility of merging 3D US data and MR images.&#xD;
&#xD;
      Further this preliminary data will be used to plan an observational study comparing healthy&#xD;
      probands and patients with incontinence.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      For the assessment of the morphology ultra sound and MRI will be used, whereas FLIP&#xD;
      (functional luminance imaging probe) and HRAM (high resolution anal manometry) are the&#xD;
      modality of choice to investigate the biomechanical properties of the sphincter complex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sphincter morphology</measure>
    <time_frame>At baseline</time_frame>
    <description>Functional sphincter variables are: anal canal length, resting, squeeze, and relaxation pressures, squeeze time, anal pressure in response to coughing, RAIR (percentage of anal relaxation), rectal volume filling to first sensation, urge and maximal tolerable volume, and distension of the anal canal in response to different filling volumes. Anatomical parameters are: distinction between internal and external sphincter (yes/no), sphincter lengths, sphincter thickness, and sphincter volumes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test feasibility of FLIP in measuring the biomechanical properties of the anal canal</measure>
    <time_frame>At baseline</time_frame>
    <description>Test the ability of FLIP in order to assess the biomechanical properties of the human anal sphincter complex in sufficient quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test feasibility of merging 3D US data and MR images</measure>
    <time_frame>At baseline</time_frame>
    <description>Test feasibility of merging 3D US data and 3D MR images (full body MR and endoanal coil MR) in order to get a more precise anatomical image at once</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>All study participants</arm_group_label>
    <description>Healthy (m/f), normal weighted</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI (magnetic resonance imaging)</intervention_name>
    <description>Assessment of the sphincter morphology</description>
    <arm_group_label>All study participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>US (ultra sound)</intervention_name>
    <description>Assessment of the sphincter morphology</description>
    <arm_group_label>All study participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FLIP (functional luminal imaging probe)</intervention_name>
    <description>Assessment of the biomechanical properties of the sphincter region</description>
    <arm_group_label>All study participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HRAM (high resolution anal manometry)</intervention_name>
    <description>Assessment of the biomechanical properties of the sphincter region</description>
    <arm_group_label>All study participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited by flyers and advertisement in internet.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
          -  Absence of ano-rectal or pelvic floor symptoms (patient history, Wexner score and&#xD;
             Longo's obstructed defecation syndrome (ODS) score =0. Appendix Constipation and&#xD;
             Faecal Incontinence Score form)&#xD;
&#xD;
          -  MRI safety (no metallic implants. Appendix MRI safety form)&#xD;
&#xD;
          -  Normal weighted (20&lt;BMI&lt;30)&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Other clinically significant concomitant disease states (e.g., renal failure, hepatic&#xD;
             dysfunction, cardiovascular disease, etc.)&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
&#xD;
          -  age (&lt;18 years old)&#xD;
&#xD;
          -  history of complicated child delivery&#xD;
&#xD;
          -  previous anorectal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bert Müller, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Biomaterials Science Center (BMC) University of Basel c/o University Hospital Basel 4031 Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik für Viszerale Chirurgie und Medizin Bauchzentrum Bern (Inselspital Bern)</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.nano-tera.ch/projects/341.php</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>November 23, 2015</last_update_submitted>
  <last_update_submitted_qc>November 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenobarbital</mesh_term>
  </intervention_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/NCT02263170
org study id: KEK-BE: 048/2014
nct id: NCT02263170
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary
      consortium consisting of representatives ranging from clinical medicine via microelectronics
      towards biomaterial science aims to develop a novel implant to treat faecal incontinence. The
      aim of this campaign includes development of implantable prototype devices acting as
      artificial continence muscles using low-voltage electrically activated polymers (EAPs)
      controlled by implemented pressure sensors and the patient.

      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal
      sphincter complex are of cardinal importance. Most of the existing data on anatomy and
      physiology results is based on old studies and almost no data on biomechanical properties are
      available. However, new technologies or even merging data from different examination methods
      might provide new information in this field.
Background

      Fecal incontinence (FI) is affecting self-confidence and can lead to social isolation and
      even loss of employment Often conservative treatment as the first option is ineffective and
      surgical interventions follow conservative are necessary.

      Small defects of the anal sphincter muscles might be treated with sphincter repair and sacral
      neuromodulation (SNM) However, patients rarely become fully continent or short-term results
      deteriorate in the long term [1]. Those patients and patients with large defects are
      candidates for a neosphincter procedure (artificial bowel sphincter or graciloplasty).
      However, the success rate of these methods is limited and the explantation rate is high. A
      permanent colostomy associated with massive psychosocial impairment remains as ultimate
      treatment option With the project Smart Muscle for Incontinence Treatment (SMIT) a
      multidisciplinary consortium consisting of representatives ranging from clinical medicine via
      microelectronics towards biomaterial science aims to develop a novel implant to treat faecal
      incontinence. The aim of this campaign includes development of implantable prototype devices
      acting as artificial continence muscles using low-voltage electrically activated polymers
      (EAPs) controlled by implemented pressure sensors and the patient.

      Subsequently, the knowledge of the anatomical and biomechanical properties of the anal
      sphincter complex are of cardinal importance. Most of the existing data on anatomy and
      physiology results is based on old studies and almost no data on biomechanical properties are
      available. However, new technologies or even merging data from different examination methods
      might provide new information in this field.

      Accurate imaging data on the pelvic floor region is crucial for the development of a new,
      implantable device for restoration of fecal continence. Optimal size (inner, outer diameter,
      length) and geometrical shape (cylinder, cone, torus) adapted to different functional states
      (rest, squeezing, defecation) will improve function and prevent erosion and consequent
      infection of such a prosthesis.

      With this study, the investigators aim to correlate three-dimensional endoanal
      ultrasonographic images with MRI images. The combination of different imaging techniques has
      been demonstrated to eliminate individual drawbacks of the examination methods and therefore
      would allow a precise description of the tissue [2]. The registered data with their
      complementary information would permit the distinct segmentation and three-dimensional
      presentations of the anatomical structures in the pelvic area. This information has a great
      potential to facilitate diagnostics and surgical planning in this region.

      High-resolution anal manometry (HRAM) provides intra-anal pressure during rest or maximum
      pressure with high spatial and time resolution.

      However Biomechanical properties of the anal canal as elasticity or stiffness (compliance or
      flexibility) of the tissue representing important parameters for a continence organ are not
      routinely evaluated in daily clinical practice. Functional Lumen Imaging Probe (FLIP) allows
      the measurement of a cross sectional area (CSA) with respect to applied luminal pressure,
      respectively. FLIP has the potential to be useful in order to assess the biomechanical
      properties of the sphincter region. Such information potentially gives new insights in
      physiology and pathophysiology of the continence process.

      With this pilot study, the investigators aim to acquire anatomical and biomechanical data
      using established (manometry) and novel technologies (merging endoanal ultrasound and MRI
      data) in 20 healthy probands (10 male, 10 female).

      Objective

      Primary objective is to collect anatomical, physiological and biomechanical characteristics
      of the continence organ (sphincters and pelvic floor) in order to specify properties of a new
      implant for the treatment of faecal incontinence.

      Secondary objectives are: test feasibility of FLIP in measuring the biomechanical properties
      of the anal canal and test feasibility of merging 3D US data and MR images.

      Further this preliminary data will be used to plan an observational study comparing healthy
      probands and patients with incontinence.

      Methods

      For the assessment of the morphology ultra sound and MRI will be used, whereas FLIP
      (functional luminance imaging probe) and HRAM (high resolution anal manometry) are the
      modality of choice to investigate the biomechanical properties of the sphincter complex.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Sphincter morphology
time frame: At baseline
description: Functional sphincter variables are: anal canal length, resting, squeeze, and relaxation pressures, squeeze time, anal pressure in response to coughing, RAIR (percentage of anal relaxation), rectal volume filling to first sensation, urge and maximal tolerable volume, and distension of the anal canal in response to different filling volumes. Anatomical parameters are: distinction between internal and external sphincter (yes/no), sphincter lengths, sphincter thickness, and sphincter volumes.
measure: Test feasibility of FLIP in measuring the biomechanical properties of the anal canal
time frame: At baseline
description: Test the ability of FLIP in order to assess the biomechanical properties of the human anal sphincter complex in sufficient quality
measure: Test feasibility of merging 3D US data and MR images
time frame: At baseline
description: Test feasibility of merging 3D US data and 3D MR images (full body MR and endoanal coil MR) in order to get a more precise anatomical image at once
arm group label: All study participants
description: Healthy (m/f), normal weighted
intervention type: Other
intervention name: MRI (magnetic resonance imaging)
description: Assessment of the sphincter morphology
arm group label: All study participants
intervention type: Other
intervention name: US (ultra sound)
description: Assessment of the sphincter morphology
arm group label: All study participants
intervention type: Other
intervention name: FLIP (functional luminal imaging probe)
description: Assessment of the biomechanical properties of the sphincter region
arm group label: All study participants
intervention type: Other
intervention name: HRAM (high resolution anal manometry)
description: Assessment of the biomechanical properties of the sphincter region
arm group label: All study participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bert Müller, Prof. Dr.
role: Study Director
affiliation: Biomaterials Science Center (BMC) University of Basel c/o University Hospital Basel 4031 Basel
facility: 
country: Switzerland
url: http://www.nano-tera.ch/projects/341.php
description: Related Info
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Phenobarbital