<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/NCT01698138</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1151</org_study_id>
    <nct_id>NCT01698138</nct_id>
  </id_info>
  <brief_title>Prevention of Bladder Dysfunction in Acute Spinal Cord Injury</brief_title>
  <acronym>BOT-SCI</acronym>
  <official_title>Prevention of Bladder Dysfunction in Acute Spinal Cord Injury. A Double-blind, Randomized, Placebo-controlled Study to Explore the Effect of Early Treatment With Onabotulinumtoxin A on Development of Detrusor Overactivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sunnaas Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double blind, randomized, placebo controlled trial to explore the effect of&#xD;
      early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord&#xD;
      injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20&#xD;
      patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml&#xD;
      NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same&#xD;
      procedure. The treatment will be repeated after three months. All included patients will be&#xD;
      evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The&#xD;
      primary endpoint of the study is development of NDO.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 20, 2020</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urodynamic parameters</measure>
    <time_frame>12 months</time_frame>
    <description>Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of complications.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Detrusor pathophysiology</measure>
    <time_frame>12 months</time_frame>
    <description>Differences in levels of transmitters and receptors relevant to development of bladder dysfunction, measured in urine samples and bladder biopsies, to gain knowledge of the pathophysiology behind neurogenic detrusor overactivity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Urinary Bladder, Overactive</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 transurethral injections, each of 1 ml solution containing NaCl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Onabotulinumtoxin A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, &quot;Allergan&quot;) in 30 ml of NaCl 0.9 %.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Onabotulinumtoxin A</intervention_name>
    <description>30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, &quot;Allergan&quot;) in 30 ml of NaCl 0.9 %.</description>
    <arm_group_label>Onabotulinumtoxin A</arm_group_label>
    <other_name>Botox ®, &quot;Allergan&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>30 transurethral injections, each of 1 ml solution containing NaCl.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>NaCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with documented acute, motor complete C6 to Th11 spinal cord injury&#xD;
&#xD;
          -  Patients can be included in the study less than four weeks after injury&#xD;
&#xD;
          -  Male or female, aged 18 to 80 years old&#xD;
&#xD;
          -  Patient weight &gt; 40 kg&#xD;
&#xD;
          -  Patient is able and willing to sign informed consent&#xD;
&#xD;
          -  Patient is able to complete all study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurogenic detrusor overactivity with contractions greater than 40 cm H2O at first&#xD;
             visit&#xD;
&#xD;
          -  History or evidence of previous urological abnormalities, disease or surgery, except&#xD;
             bladder dysfunction after spinal cord injury&#xD;
&#xD;
          -  History of haematuria or ongoing haematuria, if the hematuria is determined to be a&#xD;
             pathologic condition or is uninvestigated&#xD;
&#xD;
          -  Pregnancy or females of childbearing potential unwilling to use a reliable form of&#xD;
             contraception&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Known allergy to Onabotulinumtoxin A&#xD;
&#xD;
          -  Grave psychiatric disorder&#xD;
&#xD;
          -  Use of anti-platelet or anti-coagulant other than low molecular weight heparin (LMWH)&#xD;
             or acetylsalicylic acid&#xD;
&#xD;
          -  Haemophilia or other clotting disorders that cause bleeding diathesis&#xD;
&#xD;
          -  Treatment with antimuscarinic medication within 3 months of randomization&#xD;
&#xD;
          -  Treatment with botulinum toxin of any serotype within 3 months of randomization&#xD;
&#xD;
          -  Patient has been immunized for any botulinum toxin serotype&#xD;
&#xD;
          -  Patient has any medical condition that may put the patient at increased risk with&#xD;
             exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert&#xD;
             syndrome or amyotrophic lateral sclerosis&#xD;
&#xD;
          -  Patient has any condition or situation, which, in the investigator's opinion, puts the&#xD;
             patient at significant risk, could confound the study results, or may interfere&#xD;
             significantly with the patient's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Frich, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ole Jacob Nilsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Glott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnaas Rehabilitation Hospital, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnaas Hospital</name>
      <address>
        <city>Nesoddtangen</city>
        <zip>1450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0027</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Lars Frich</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Spinal cord injury</keyword>
  <keyword>Neurogenic overactive bladder</keyword>
  <keyword>Onabotulinum toxin A</keyword>
  <keyword>Prevention</keyword>
  <keyword>Botulinum Toxins, Type A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</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/NCT01698138
org study id: 2012/1151
nct id: NCT01698138
lead sponsor: 
collaborator: 
has dmc: No
This study is a double blind, randomized, placebo controlled trial to explore the effect of
      early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord
      injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20
      patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml
      NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same
      procedure. The treatment will be repeated after three months. All included patients will be
      evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The
      primary endpoint of the study is development of NDO.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.
time frame: 12 months
measure: Urodynamic parameters
time frame: 12 months
description: Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.
measure: Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.
time frame: 12 months
measure: Occurrence of complications.
time frame: 12 months
measure: Detrusor pathophysiology
time frame: 12 months
description: Differences in levels of transmitters and receptors relevant to development of bladder dysfunction, measured in urine samples and bladder biopsies, to gain knowledge of the pathophysiology behind neurogenic detrusor overactivity.
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 transurethral injections, each of 1 ml solution containing NaCl.
arm group label: Onabotulinumtoxin A
arm group type: Active Comparator
description: 30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
intervention type: Drug
intervention name: Onabotulinumtoxin A
description: 30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
arm group label: Onabotulinumtoxin A
other name: Botox ®, "Allergan"
intervention type: Drug
intervention name: Placebo
description: 30 transurethral injections, each of 1 ml solution containing NaCl.
arm group label: Placebo
other name: NaCl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lars Frich, MD, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Ole Jacob Nilsen, MD
role: Principal Investigator
affiliation: University of Oslo
last name: Thomas Glott, MD
role: Principal Investigator
affiliation: Sunnaas Rehabilitation Hospital, Norway
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Lars Frich
investigator title: MD, PhD
mesh term: Spinal Cord Injuries
mesh term: Urinary Bladder, Overactive
mesh term: Wounds and Injuries
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA