<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/NCT01682603</url>
  </required_header>
  <id_info>
    <org_study_id>TCGHUROL005</org_study_id>
    <nct_id>NCT01682603</nct_id>
  </id_info>
  <brief_title>Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients</brief_title>
  <official_title>Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients - Clinical Effects and Investigating Mechanism of Action</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Buddhist Tzu Chi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Buddhist Tzu Chi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on&#xD;
      neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of&#xD;
      expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of&#xD;
      patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedure&#xD;
&#xD;
      A total of 30 patients with chronic suprasacral cord SCI will be enrolled in this study. All&#xD;
      patients are more than 18 years old and have chronic suprasacral cord injury for more than 1&#xD;
      year. They have previously underwent an urodynamic study and have been proven having detrusor&#xD;
      sphincter dyssynergia (DSD). The patients currently void by reflex, abdominal stimulation or&#xD;
      clean intermittent catheterization (CIC), are free of indwelling catheter or cystostomy, and&#xD;
      free of urinary tract infection (UTI) on their enrollment. During the screening period, a&#xD;
      total glomerular filtration rate (GFR) should be less than 80 mL/min as measured by&#xD;
      99mTc-labelled diethylenetriamine pentaacetic acid (99mTc-DTPA) clearance renal scanning.&#xD;
      Patients should also have adequate hand function or have a care-giver available for CIC.&#xD;
      Other exclusion criteria include patients with detrusor underactivity and large bladder&#xD;
      compliance, patients proven to have intrinsic sphincteric deficiency and patients who have&#xD;
      hypersensitivity to botulinum toxin A (BTX-A) or constituent ingredients of BTX-A.&#xD;
&#xD;
      BTX-A injection will be performed in the operation room under light intravenous general&#xD;
      anesthesia to prevent autonomic dysreflexia and hyperreflexia during cystoscopy. A total of&#xD;
      300U BTX-A (BOTOX, 100 U/vial, Allergan Co., Irvine, USA) dissolved into 30 mL normal saline&#xD;
      will be injected into 30 sites of the bladder including lateral, posterior wall and dome. The&#xD;
      injection sites are widely distributed to cover the whole bladder wall. A 14 Fr Foley&#xD;
      catheter will be routinely inserted after BTX-A injection and patients will be discharged the&#xD;
      next morning and followed up at out-patient clinic. All patients will be instructed to keep&#xD;
      on CIC or abdominal stimulation as they previously performed. BTX-A injections will be&#xD;
      repeated 6 months after the first treatment, then follow up to 24 months. Before each BTX-A&#xD;
      injection a videourodynamic study and GFR test will be performed. Patients were also&#xD;
      requested to report the severity of urinary incontinence by the mean daily incontinence&#xD;
      episodes within three days, Urogenital Distress Inventory (UDI-6 Short Form), Incontinence&#xD;
      Impact Questionnaire (IIQ-7), self assessed QoL index and the global satisfaction rate&#xD;
      (graded as 0 to 3, indicating none, mild, moderate and very satisfied) to this treatment. The&#xD;
      adverse events such as urinary tract infection, hematuria, difficult urination are also&#xD;
      recorded.&#xD;
&#xD;
      This study should be approved by the Institutional Review Board and Ethics Committee of the&#xD;
      hospital. Informed consent will be obtained before the screening and all patients are&#xD;
      instructed about the possible complications related with BTX-A injection such as urinary&#xD;
      retention, transient hematuria and subsequent urinary tract infection.&#xD;
&#xD;
      Patients will be classified as responders and non-responders according to their clinical&#xD;
      presentation and urodynamic study results. Responders are considered if they become dry or&#xD;
      reduction of incontinence episodes by 50% and have a decrease of detrusor pressure reduction&#xD;
      by 50% of the baseline value, otherwise, they are considered as non-responders. The end-point&#xD;
      is set at 6 months after the BTX-A injection.&#xD;
&#xD;
      There were two primary end-points: (1) the net change of the IIQ-7 and UDI-6 from baseline to&#xD;
      24 months, and (2) the net change of the GFR from baseline to 24 months. Secondary end-point&#xD;
      efficacy measured the net change of the cystometric bladder capacity, bladder compliance,&#xD;
      detrusor pressure during reflex voiding, end-filling pressure or detrusor leak-point pressure&#xD;
      and postvoid residual volume from baseline to 24 months.&#xD;
&#xD;
      Three bladder biopsies using a small cystoscopic biopsy forceps will be performed in all&#xD;
      patients. The biopsy will be performed at baseline and each time-point just prior to&#xD;
      intravesical BTX-A injection. The bladder biopsy specimens will be sent to pathological&#xD;
      department for H-E staining to exclude the possibility of carcinoma in situ, and also will be&#xD;
      embedded in O.C.T. medium and stored at -80℃ refrigerator or liquid nitrogen tank for&#xD;
      investigations. The bladder biopsies will be prepared for measurement of NGF messenger RNA&#xD;
      (mRNA) and immunohistochemistry investigation of the expression of Transient Receptor&#xD;
      Potential Vanilloid 1 (TRPV-1), purinergic receptor P2X, ligand-gated ion channel, 3 (P2X3)&#xD;
      receptors at baseline and 6 months after each BTX-A injection, and the difference of these&#xD;
      sensory protein expressions between responders and .non-responders to BTX-A injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net Change of the Urinary Distress Inventory (UDI-6)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.&#xD;
The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Net Change of the Incontinence Impact Questionnaire (IIQ-7)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.&#xD;
The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Net Change of the Quality of Life Index (QoL-I)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;. The QoL-I ranges 0 to 6&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Cystometric Bladder Capacity (CBC)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the cystometric bladder capacity (CBC) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Bladder Compliance</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.&#xD;
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).&#xD;
Efficacy:&#xD;
Net change of the bladder compliance from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Maximum Flow Rate (Qmax)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the maximum flow rate (Qmax) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Void Volume</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the void volume from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Detrusor Pressure (Pdet)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the detrusor pressure (Pdet) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Change of the Postvoid Residual Volume (PVR)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Efficacy:&#xD;
Net change of the postvoid residual volume (PVR) from baseline and 12 months&#xD;
Results:&#xD;
Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.&#xD;
Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Autonomic Dysreflexia</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BoNT-A (BOTOX 300U)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin A</intervention_name>
    <description>BoNT-A (BOTOX 300U)</description>
    <arm_group_label>Botulinum toxin A</arm_group_label>
    <other_name>BoNT-A (BOTOX 300U)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with age of 19 years old or above&#xD;
&#xD;
          -  Patients with chronic suprasacral cord SCI will be enrolled.&#xD;
&#xD;
          -  Patients will be proven having NDO by videourodynamic study during the screening&#xD;
             period.&#xD;
&#xD;
          -  They also receive 99mTc-DTPA renal scanning for GFR at baseline.&#xD;
&#xD;
          -  Patients with NDO induced urinary incontinence who have adequate hand function or have&#xD;
             a care-giver available for CIC, and the baseline total GFR of less than 80 mL/min are&#xD;
             main inclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with detrusor underactivity and large bladder compliance, patients proven to&#xD;
             have intrinsic sphincteric deficiency&#xD;
&#xD;
          -  Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hann-Chorng Kuo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buddhist Tzu Chi General Hospital</name>
      <address>
        <city>Hualien</city>
        <zip>970</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>May 16, 2014</results_first_submitted>
  <results_first_submitted_qc>June 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 23, 2014</results_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Buddhist Tzu Chi General Hospital</investigator_affiliation>
    <investigator_full_name>Hann-Chorng Kuo</investigator_full_name>
    <investigator_title>Director of Urology</investigator_title>
  </responsible_party>
  <keyword>Nerve growth factor</keyword>
  <keyword>P2X3 receptor</keyword>
  <keyword>Transient Receptor Potential Vanilloid 1 (TRPV-1) receptor</keyword>
  <keyword>Bladder function</keyword>
  <keyword>Glomerular filtration rate</keyword>
  <keyword>Detrusor overactivity</keyword>
  <keyword>Spinal cord injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The chronic SCI patients with urinary incontinence in Hualien Tzu Chi General Hospital were consecutively recruited into this study.</recruitment_details>
      <pre_assignment_details>Patients were excluded if they had an active urinary tract infection, urinary tract cancer, history of lower urinary tract surgery or chronic systemic diseases. If patients fulfilled the inclusion criteria, they were enrolled in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Botulinum Toxin A</title>
          <description>Botulinum toxin A (BoNT-A) (BOTOX 300U)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Botulinum Toxin A</title>
          <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.5" lower_limit="22" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Injury Level</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Cervical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thoracic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASIA Classification</title>
          <description>ASIA Impairment Scale A: Complete. No sensory or motor function is preserved in the sacral segments S4-S5. B: Incomplete. Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C: Incomplete. Motor function is preserved below the neurological level, and more then half of key muscles below the neurological level have a muscle grade less then 3 (Grades 0-2). D: Incomplete. Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade greater than or equal to 3.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Autonomic dysreflexia</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Autonomic dysreflexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Autonomic dysreflexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Net Change of the Urinary Distress Inventory (UDI-6)</title>
        <description>Efficacy:&#xD;
Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.&#xD;
The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Urinary Distress Inventory (UDI-6)</title>
          <description>Efficacy:&#xD;
Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.&#xD;
The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="4.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.43" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Cystometric Bladder Capacity (CBC)</title>
        <description>Efficacy:&#xD;
Net change of the cystometric bladder capacity (CBC) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Cystometric Bladder Capacity (CBC)</title>
          <description>Efficacy:&#xD;
Net change of the cystometric bladder capacity (CBC) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305.9" spread="167.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="437.6" spread="114.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Bladder Compliance</title>
        <description>Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.&#xD;
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).&#xD;
Efficacy:&#xD;
Net change of the bladder compliance from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Bladder Compliance</title>
          <description>Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.&#xD;
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).&#xD;
Efficacy:&#xD;
Net change of the bladder compliance from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>mL/cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Maximum Flow Rate (Qmax)</title>
        <description>Efficacy:&#xD;
Net change of the maximum flow rate (Qmax) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Maximum Flow Rate (Qmax)</title>
          <description>Efficacy:&#xD;
Net change of the maximum flow rate (Qmax) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>mL/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.54" spread="8.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Void Volume</title>
        <description>Efficacy:&#xD;
Net change of the void volume from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Void Volume</title>
          <description>Efficacy:&#xD;
Net change of the void volume from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6" spread="95.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2" spread="125.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Detrusor Pressure (Pdet)</title>
        <description>Efficacy:&#xD;
Net change of the detrusor pressure (Pdet) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Detrusor Pressure (Pdet)</title>
          <description>Efficacy:&#xD;
Net change of the detrusor pressure (Pdet) from baseline and 12 months&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Net Change of the Postvoid Residual Volume (PVR)</title>
        <description>Efficacy:&#xD;
Net change of the postvoid residual volume (PVR) from baseline and 12 months&#xD;
Results:&#xD;
Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.&#xD;
Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Postvoid Residual Volume (PVR)</title>
          <description>Efficacy:&#xD;
Net change of the postvoid residual volume (PVR) from baseline and 12 months&#xD;
Results:&#xD;
Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.&#xD;
Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.3" spread="138.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="378.5" spread="142.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Net Change of the Incontinence Impact Questionnaire (IIQ-7)</title>
        <description>Efficacy:&#xD;
Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.&#xD;
The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Incontinence Impact Questionnaire (IIQ-7)</title>
          <description>Efficacy:&#xD;
Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.&#xD;
The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 &quot;Not at all&quot; to 3 &quot;Greatly&quot;.&#xD;
Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="5.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.57" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Net Change of the Quality of Life Index (QoL-I)</title>
        <description>Efficacy:&#xD;
Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;. The QoL-I ranges 0 to 6&#xD;
Safety:&#xD;
Systemic adverse events</description>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin A</title>
            <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
          </group>
        </group_list>
        <measure>
          <title>Net Change of the Quality of Life Index (QoL-I)</title>
          <description>Efficacy:&#xD;
Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;. The QoL-I ranges 0 to 6&#xD;
Safety:&#xD;
Systemic adverse events</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Autonomic Dysreflexia</title>
        <time_frame>Baseline and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pre-Autonomic Dysreflexia</title>
            <description>Baseline Autonomic dysreflexia</description>
          </group>
          <group group_id="O2">
            <title>Pre-Non Autonomic Dysreflexia</title>
            <description>Baseline Non autonomic dysreflexia</description>
          </group>
        </group_list>
        <measure>
          <title>Autonomic Dysreflexia</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Autonomic dysreflexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Non Autonomic dysreflexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Botulinum Toxin A</title>
          <description>BoNT-A (BOTOX 300U)&#xD;
Botulinum toxin A: BoNT-A (BOTOX 300U)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>De nove autonomic dysreflexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Difficult urination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hann-Chorng Kuo</name_or_title>
      <organization>Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University</organization>
      <phone>886-3-8561825 ext 2113</phone>
      <email>hck@tzuchi.com.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01682603
org study id: TCGHUROL005
nct id: NCT01682603
lead sponsor: 
has dmc: No
To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on
      neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of
      expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of
      patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)
      patients.
Study Procedure

      A total of 30 patients with chronic suprasacral cord SCI will be enrolled in this study. All
      patients are more than 18 years old and have chronic suprasacral cord injury for more than 1
      year. They have previously underwent an urodynamic study and have been proven having detrusor
      sphincter dyssynergia (DSD). The patients currently void by reflex, abdominal stimulation or
      clean intermittent catheterization (CIC), are free of indwelling catheter or cystostomy, and
      free of urinary tract infection (UTI) on their enrollment. During the screening period, a
      total glomerular filtration rate (GFR) should be less than 80 mL/min as measured by
      99mTc-labelled diethylenetriamine pentaacetic acid (99mTc-DTPA) clearance renal scanning.
      Patients should also have adequate hand function or have a care-giver available for CIC.
      Other exclusion criteria include patients with detrusor underactivity and large bladder
      compliance, patients proven to have intrinsic sphincteric deficiency and patients who have
      hypersensitivity to botulinum toxin A (BTX-A) or constituent ingredients of BTX-A.

      BTX-A injection will be performed in the operation room under light intravenous general
      anesthesia to prevent autonomic dysreflexia and hyperreflexia during cystoscopy. A total of
      300U BTX-A (BOTOX, 100 U/vial, Allergan Co., Irvine, USA) dissolved into 30 mL normal saline
      will be injected into 30 sites of the bladder including lateral, posterior wall and dome. The
      injection sites are widely distributed to cover the whole bladder wall. A 14 Fr Foley
      catheter will be routinely inserted after BTX-A injection and patients will be discharged the
      next morning and followed up at out-patient clinic. All patients will be instructed to keep
      on CIC or abdominal stimulation as they previously performed. BTX-A injections will be
      repeated 6 months after the first treatment, then follow up to 24 months. Before each BTX-A
      injection a videourodynamic study and GFR test will be performed. Patients were also
      requested to report the severity of urinary incontinence by the mean daily incontinence
      episodes within three days, Urogenital Distress Inventory (UDI-6 Short Form), Incontinence
      Impact Questionnaire (IIQ-7), self assessed QoL index and the global satisfaction rate
      (graded as 0 to 3, indicating none, mild, moderate and very satisfied) to this treatment. The
      adverse events such as urinary tract infection, hematuria, difficult urination are also
      recorded.

      This study should be approved by the Institutional Review Board and Ethics Committee of the
      hospital. Informed consent will be obtained before the screening and all patients are
      instructed about the possible complications related with BTX-A injection such as urinary
      retention, transient hematuria and subsequent urinary tract infection.

      Patients will be classified as responders and non-responders according to their clinical
      presentation and urodynamic study results. Responders are considered if they become dry or
      reduction of incontinence episodes by 50% and have a decrease of detrusor pressure reduction
      by 50% of the baseline value, otherwise, they are considered as non-responders. The end-point
      is set at 6 months after the BTX-A injection.

      There were two primary end-points: (1) the net change of the IIQ-7 and UDI-6 from baseline to
      24 months, and (2) the net change of the GFR from baseline to 24 months. Secondary end-point
      efficacy measured the net change of the cystometric bladder capacity, bladder compliance,
      detrusor pressure during reflex voiding, end-filling pressure or detrusor leak-point pressure
      and postvoid residual volume from baseline to 24 months.

      Three bladder biopsies using a small cystoscopic biopsy forceps will be performed in all
      patients. The biopsy will be performed at baseline and each time-point just prior to
      intravesical BTX-A injection. The bladder biopsy specimens will be sent to pathological
      department for H-E staining to exclude the possibility of carcinoma in situ, and also will be
      embedded in O.C.T. medium and stored at -80℃ refrigerator or liquid nitrogen tank for
      investigations. The bladder biopsies will be prepared for measurement of NGF messenger RNA
      (mRNA) and immunohistochemistry investigation of the expression of Transient Receptor
      Potential Vanilloid 1 (TRPV-1), purinergic receptor P2X, ligand-gated ion channel, 3 (P2X3)
      receptors at baseline and 6 months after each BTX-A injection, and the difference of these
      sensory protein expressions between responders and .non-responders to BTX-A injection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Net Change of the Urinary Distress Inventory (UDI-6)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.
The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".
The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events
measure: Net Change of the Incontinence Impact Questionnaire (IIQ-7)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.
The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly".
Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events
measure: Net Change of the Quality of Life Index (QoL-I)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible". The QoL-I ranges 0 to 6
Safety:
Systemic adverse events
measure: Net Change of the Cystometric Bladder Capacity (CBC)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the cystometric bladder capacity (CBC) from baseline and 12 months
Safety:
Systemic adverse events
measure: Net Change of the Bladder Compliance
time frame: Baseline and 12 months
description: Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).
Efficacy:
Net change of the bladder compliance from baseline and 12 months
Safety:
Systemic adverse events
measure: Net Change of the Maximum Flow Rate (Qmax)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the maximum flow rate (Qmax) from baseline and 12 months
Safety:
Systemic adverse events
measure: Net Change of the Void Volume
time frame: Baseline and 12 months
description: Efficacy:
Net change of the void volume from baseline and 12 months
Safety:
Systemic adverse events
measure: Net Change of the Detrusor Pressure (Pdet)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the detrusor pressure (Pdet) from baseline and 12 months
Safety:
Systemic adverse events
measure: Net Change of the Postvoid Residual Volume (PVR)
time frame: Baseline and 12 months
description: Efficacy:
Net change of the postvoid residual volume (PVR) from baseline and 12 months
Results:
Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.
Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.
Safety:
Systemic adverse events
measure: Autonomic Dysreflexia
time frame: Baseline and 12 months
arm group label: Botulinum toxin A
arm group type: Experimental
description: BoNT-A (BOTOX 300U)
intervention type: Drug
intervention name: Botulinum toxin A
description: BoNT-A (BOTOX 300U)
arm group label: Botulinum toxin A
other name: BoNT-A (BOTOX 300U)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hann-Chorng Kuo, M.D.
role: Principal Investigator
affiliation: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
facility: 
country: Taiwan
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responsible party type: Principal Investigator
investigator affiliation: Buddhist Tzu Chi General Hospital
investigator full name: Hann-Chorng Kuo
investigator title: Director of Urology
mesh term: Spinal Cord Injuries
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
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