<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/NCT03261622</url>
  </required_header>
  <id_info>
    <org_study_id>005</org_study_id>
    <nct_id>NCT03261622</nct_id>
  </id_info>
  <brief_title>Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective</brief_title>
  <acronym>SNS</acronym>
  <official_title>Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient&#xD;
      treatment option for faecal incontinence (FI).&#xD;
&#xD;
      In a selected patient group we have evidence that 90% of patients will have a successful test&#xD;
      period (≥50% reduction in incontinence episodes). If preoperative there is motor response on&#xD;
      at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.&#xD;
&#xD;
      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage&#xD;
      permanent implant will be possible. The functional results will be improved as more time can&#xD;
      be spent finding the optimal pacemaker settings as the risk of infection is reduced compared&#xD;
      to the stage implant. One-Stage implantation gives the opportunity to test the amount of&#xD;
      placebo effect with SNS.&#xD;
&#xD;
      During the first 3 months postoperative patients will be randomized to either stimulation&#xD;
      amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at&#xD;
      0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2&#xD;
      pattern. After the initial 3 months the stimulation amplitude is increased to sensory&#xD;
      threshold. After six months the project ends and the number of patients achieving the 50%&#xD;
      improvement in incontinence episodes are evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient&#xD;
      treatment option for faecal incontinence (FI). The therapy is recommended by the&#xD;
      International Continence Society (ICS) if conservative treatments such as; regulation of diet&#xD;
      and fibre supplements, medication, biofeedback therapy, glycerol suppositories, mini enema or&#xD;
      transanal irrigation have been insufficient to improve continence to a satisfactory level.&#xD;
&#xD;
      The SNS therapy has traditionally been applied as a two step procedure. Firstly, a 3-4 week&#xD;
      test-period, often with a permanent electrode with tines, followed by permanent implantation&#xD;
      if at least a 50% symptom reduction has been obtained during the test stimulation.&#xD;
&#xD;
      In a selected patient group(idiopathic faecal incontinence or incontinence as a result of an&#xD;
      external anal sphincter tear (&lt;160 degrees)) we have evidence that 90% of patients will have&#xD;
      a successful test period (≥50% reduction in incontinence episodes). If preoperative there is&#xD;
      motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP(unpublished&#xD;
      data, submitted for publication) .&#xD;
&#xD;
      Thus, only 10% of the patients have the lead explanted after 3 to 4 weeks. In 90% of the&#xD;
      patients a pacemaker is implanted after the test period, these patients will have an&#xD;
      additional operation that could have been avoided if they had the permanent pacemaker&#xD;
      implanted at the first stage.&#xD;
&#xD;
      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage&#xD;
      permanent implant will be possible. The functional results will be improved as more time can&#xD;
      be spent finding the optimal pacemaker settings as the risk of infection is reduced compared&#xD;
      to the stage implant. One-Stage implantation gives the opportunity to test the amount of&#xD;
      placebo effect with SNS.&#xD;
&#xD;
      During the first 3 months postoperative patients will be randomized to either stimulation&#xD;
      amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at&#xD;
      0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2&#xD;
      pattern. After the initial 3 months the stimulation amplitude is increased to sensory&#xD;
      threshold. After six months the project ends and the number of patients achieving the 50%&#xD;
      improvement in incontinence episodes are evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Patients will be randomized to either control group (Stimulation amplitude at 90% of sensory threshold) or intervention arm (different stimulation amplitude - 0.05 V, 50 and 90% of sensory threshold)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Alle patients are stimulated sub-sensory in (3x4 weeks) and will be blinded. The investigators will not participate in the randomization, and setting of the stimulation amplitude.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel Habit Diary changes</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bowel Habit Diary changes</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bowel Habit Diary</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome measure - Wexner Incontinence score</measure>
    <time_frame>4, 8, 12, and 24 weeks</time_frame>
    <description>Changes in Wexner incontinence score, compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome measure - St. Marks incontinence score</measure>
    <time_frame>4, 8, 12, and 24 weeks</time_frame>
    <description>Changes in St. Marks incontinence score, compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life FI - specific</measure>
    <time_frame>4, 8, 12, and 24 weeks</time_frame>
    <description>Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional outcome - Urin incontinence (UI).</measure>
    <time_frame>4, 8, 12, and 24 weeks</time_frame>
    <description>ICIQ_UI Short form,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue score (VAS score): patients overall satisfaction</measure>
    <time_frame>4, 8, 12, and 24 weeks</time_frame>
    <description>VAS-score (0-100) for patients satisfaction with overall:&#xD;
Social function&#xD;
Bowel function&#xD;
Quality of life Baseline value used as reference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anal physiology test</measure>
    <time_frame>baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)</time_frame>
    <description>Functional Lumen Imaging Probe (endoFLIP) and anal sensibility. The endoFLIP allows dynamic examination of the geometry and segmental distensibility properties of the anal canal by simultaneous measurement of anal pressure(PSI) and luminal cross sectional areas (CSAs) at 16 points along the length of the anal canal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Faecal Incontinence</condition>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Alternation of stimulation amplitude&#xD;
Period - Stimulation amplitude 0.05 Volts (lowest possible)&#xD;
Period - Stimulation amplitude - 50% of sensory threshold.&#xD;
Period - Stimulation amplitude - 90% of sensory threshold.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sacral nerve stimulation at different stimulation amplitudes</intervention_name>
    <description>Exploring the effect of different stimulation amplitude in a randomized study</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Idiopathic faecal incontinence or incontinence following external sphincter tear ≤ 160&#xD;
             degrees.&#xD;
&#xD;
          -  ≥ one faecal incontinence episode after optimized conservative treatment.&#xD;
&#xD;
          -  Ability to use the patient programmer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Neurological diseases, including spinal cord injuries&#xD;
&#xD;
          -  Pelvic irradiation&#xD;
&#xD;
          -  Rectal resections&#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>Jakob K. Jakobsen, MD. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jakob K. Jakobsen, MD. Ph.D.</last_name>
    <email>jakob_jakobsen@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Aarhus C</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jakob K Jakobsen, MD, Ph.D.</last_name>
      <email>jakob_jakobsen@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Steen Buntzen, MD, DMSc.</last_name>
      <email>steen.buntzen@dadelnet.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Jakob K Jakobsen, MD, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Jakob Jakobsen</investigator_full_name>
    <investigator_title>Principal Investigator (M.D. Ph.D.)</investigator_title>
  </responsible_party>
  <keyword>Sacral Nerve Stimulation</keyword>
  <keyword>Sacral Nerve Modulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All participants in the study group have access to the data and if agreed in the study group sub-analysis can be made after the trial has ended.</ipd_description>
  </patient_data>
  <!-- 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/NCT03261622
org study id: 005
nct id: NCT03261622
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient
      treatment option for faecal incontinence (FI).

      In a selected patient group we have evidence that 90% of patients will have a successful test
      period (≥50% reduction in incontinence episodes). If preoperative there is motor response on
      at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.

      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage
      permanent implant will be possible. The functional results will be improved as more time can
      be spent finding the optimal pacemaker settings as the risk of infection is reduced compared
      to the stage implant. One-Stage implantation gives the opportunity to test the amount of
      placebo effect with SNS.

      During the first 3 months postoperative patients will be randomized to either stimulation
      amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at
      0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2
      pattern. After the initial 3 months the stimulation amplitude is increased to sensory
      threshold. After six months the project ends and the number of patients achieving the 50%
      improvement in incontinence episodes are evaluated.
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient
      treatment option for faecal incontinence (FI). The therapy is recommended by the
      International Continence Society (ICS) if conservative treatments such as; regulation of diet
      and fibre supplements, medication, biofeedback therapy, glycerol suppositories, mini enema or
      transanal irrigation have been insufficient to improve continence to a satisfactory level.

      The SNS therapy has traditionally been applied as a two step procedure. Firstly, a 3-4 week
      test-period, often with a permanent electrode with tines, followed by permanent implantation
      if at least a 50% symptom reduction has been obtained during the test stimulation.

      In a selected patient group(idiopathic faecal incontinence or incontinence as a result of an
      external anal sphincter tear (<160 degrees)) we have evidence that 90% of patients will have
      a successful test period (≥50% reduction in incontinence episodes). If preoperative there is
      motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP(unpublished
      data, submitted for publication) .

      Thus, only 10% of the patients have the lead explanted after 3 to 4 weeks. In 90% of the
      patients a pacemaker is implanted after the test period, these patients will have an
      additional operation that could have been avoided if they had the permanent pacemaker
      implanted at the first stage.

      Hypotheses In a selected patient group suffering from faecal incontinence a one-stage
      permanent implant will be possible. The functional results will be improved as more time can
      be spent finding the optimal pacemaker settings as the risk of infection is reduced compared
      to the stage implant. One-Stage implantation gives the opportunity to test the amount of
      placebo effect with SNS.

      During the first 3 months postoperative patients will be randomized to either stimulation
      amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at
      0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2
      pattern. After the initial 3 months the stimulation amplitude is increased to sensory
      threshold. After six months the project ends and the number of patients achieving the 50%
      improvement in incontinence episodes are evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to either control group (Stimulation amplitude at 90% of sensory threshold) or intervention arm (different stimulation amplitude - 0.05 V, 50 and 90% of sensory threshold)
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Alle patients are stimulated sub-sensory in (3x4 weeks) and will be blinded. The investigators will not participate in the randomization, and setting of the stimulation amplitude.
measure: Bowel Habit Diary changes
time frame: 12 weeks
description: Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
measure: Bowel Habit Diary changes
time frame: 4 weeks
description: Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
measure: Bowel Habit Diary
time frame: 24 weeks
description: Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
measure: Functional outcome measure - Wexner Incontinence score
time frame: 4, 8, 12, and 24 weeks
description: Changes in Wexner incontinence score, compared to baseline.
measure: Functional outcome measure - St. Marks incontinence score
time frame: 4, 8, 12, and 24 weeks
description: Changes in St. Marks incontinence score, compared to baseline.
measure: Quality of Life FI - specific
time frame: 4, 8, 12, and 24 weeks
description: Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline
measure: Changes in functional outcome - Urin incontinence (UI).
time frame: 4, 8, 12, and 24 weeks
description: ICIQ_UI Short form,
measure: Visual analogue score (VAS score): patients overall satisfaction
time frame: 4, 8, 12, and 24 weeks
description: VAS-score (0-100) for patients satisfaction with overall:
Social function
Bowel function
Quality of life Baseline value used as reference
measure: Anal physiology test
time frame: baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)
description: Functional Lumen Imaging Probe (endoFLIP) and anal sensibility. The endoFLIP allows dynamic examination of the geometry and segmental distensibility properties of the anal canal by simultaneous measurement of anal pressure(PSI) and luminal cross sectional areas (CSAs) at 16 points along the length of the anal canal
arm group label: Control arm
arm group type: Active Comparator
description: Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)
arm group label: Intervention arm
arm group type: Sham Comparator
description: Alternation of stimulation amplitude
Period - Stimulation amplitude 0.05 Volts (lowest possible)
Period - Stimulation amplitude - 50% of sensory threshold.
Period - Stimulation amplitude - 90% of sensory threshold.
intervention type: Device
intervention name: Sacral nerve stimulation at different stimulation amplitudes
description: Exploring the effect of different stimulation amplitude in a randomized study
arm group label: Control arm
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jakob K. Jakobsen, MD. Ph.D.
role: Principal Investigator
affiliation: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
last name: Jakob K. Jakobsen, MD. Ph.D.
email: jakob_jakobsen@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Jakob Jakobsen
investigator title: Principal Investigator (M.D. Ph.D.)
mesh term: Fecal Incontinence
sharing ipd: Yes
ipd description: All participants in the study group have access to the data and if agreed in the study group sub-analysis can be made after the trial has ended.