<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/NCT01733290</url>
  </required_header>
  <id_info>
    <org_study_id>TCGHUROL006</org_study_id>
    <nct_id>NCT01733290</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding</brief_title>
  <official_title>Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding - A Multicenter Study, Randomized, Double-Blind, Placebo Control</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>
      This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients&#xD;
      with dysfunctional voiding. The results of this study can provide further information for&#xD;
      patient selection and therapeutic duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed in a randomized, double-blind, placebo controlled, multicentric trial.&#xD;
      A total of 60 patients will be enrolled. All patients have suffered from dysfunctional&#xD;
      voiding that is refractory to conventional treatment. The enrolled patients should have&#xD;
      severe dysuria or urinary retention, large residual urine and have been treated with&#xD;
      medication or other therapeutic modality for over 3 months. The patients will be randomly&#xD;
      assigned to allocate in the treatment and control groups in a 2:1 ratio. About 40 and 20&#xD;
      patients will be enrolled in the treatment and control group, respectively.&#xD;
&#xD;
      This study should be approved by the Institutional Review Board (IRB) and ethical committee&#xD;
      of the hospital. Every patient should be thoroughly informed and written informed consent&#xD;
      should be obtained before treatment.&#xD;
&#xD;
      Patients will receive a complete urological work-up before treatment, including urinalysis,&#xD;
      urine culture, cystoscopy to prove no anatomical stricture or lower urinary tract pathology,&#xD;
      and videourodynamic study. All medication that may affect the lower urinary tract function&#xD;
      will be stopped at least 1 week before Botulinum Toxin A (BoNT-A) injection.&#xD;
&#xD;
      Videourodynamic study will be performed with the patient in supine position if patients&#xD;
      cannot stand up or sit on the commode. A 6 Fr dual channel urethral pressure profiles (UPP)&#xD;
      urethral catheter will be inserted to the urinary bladder. After evacuation of the residual&#xD;
      urine, urethral pressure profilometry will be performed first. Then the bladder will be&#xD;
      filled with normal saline containing 20% urografin at the filling rate of 30 ml/min. The&#xD;
      filling and voiding cystourethrography will be investigated by a C-arm positioned below the&#xD;
      patient. Uroflowmetry is recorded by a weighed transducer placed below the examination table.&#xD;
      After the bladder is filled to the capacity, the patients are asked to urinate per urethrae.&#xD;
      If patient cannot urinate per urethrae with the urethral catheter in situ, suprapubic&#xD;
      puncture with a 18 Gauge needle and a 3-Fr epidural catheter will be undertaken and patients&#xD;
      will urinate without the catheter in the urethra. The patients are requested to stand up and&#xD;
      urinate into the commode. Pressure flow study and concomitant voiding cystourethrography are&#xD;
      performed.&#xD;
&#xD;
      The urodynamic parameters include maximal urethral closure pressure (MUCP), functional&#xD;
      profile length (FPL), cystometric bladder capacity (CBC), bladder compliance, voiding&#xD;
      detrusor pressure (Pdet), maximal flow rate (Qmax), voided volume, and postvoid residual&#xD;
      urine volume (PVR). In the patients who have detrusor underactivity, the abdominal pressure&#xD;
      to urinate and the detrusor leak point pressure will be measured. Images of voiding&#xD;
      cystourethrography will be emphasized on the bladder neck opening, urethral sphincter&#xD;
      relaxation, and dilatation of posterior urethra during voiding.&#xD;
&#xD;
      Patients will be admitted and BoNT-A (treatment group) or normal saline (control group)&#xD;
      injections will be performed in the operation room where complete cardiovascular monitoring&#xD;
      is available during the operation. BoNT-A injections are made under cystoscopy guide in male&#xD;
      patients and injecting periurethrally in female patients. The BoNT-A will be purchased from&#xD;
      Allergan Company (Botox, 100 units/vial, Irvine, California, U.S.A.). Each vial of BoNT-A&#xD;
      will be diluted to 5 ml by normal saline. A total of 100 units of BoNT-A will be injected&#xD;
      deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate&#xD;
      equal aliquot. After BoNT-A injections, a 14 Fr Foley catheter will be indwelled routinely&#xD;
      for 1 day and then removed. Patients will be followed up for their voiding conditions. When&#xD;
      dysuria persists, intermittent catheterization will be advised instead of indwelling Foley&#xD;
      catheter. Antibiotics will not be necessary unless urinary tract infection occurs, and&#xD;
      medications to reduce urethral sphincteric resistance are discontinued.&#xD;
&#xD;
      Patients will be closely contacted and monitored by the research assistant by telephone. They&#xD;
      will be followed up at out-patient clinic at 1 week, 2 weeks and 4 weeks after BoNT-A&#xD;
      injections. After the first month after initial BoNT-A injection, patients will be followed&#xD;
      up monthly until the therapeutic effect is gone. Videourodynamic study and UPP study will be&#xD;
      performed at 4 weeks after BoNT-A injections. The subjective improvement of voiding condition&#xD;
      will be assessed by the obstructive symptom scores (including hesitancy, intermittency,&#xD;
      dysuria, small caliber of urine) and quality of life score which are adopted from the&#xD;
      International Prostate Symptom Score (IPSS) system.&#xD;
&#xD;
      The primary end-point is the change of Patient Perception of Bladder Condition (PPBC) at 4&#xD;
      weeks after the initial injection. If patients have a PPBC improved by two scales, they are&#xD;
      considered as successfully treated, otherwise failed treatment. The subjective symptom score,&#xD;
      quality of life score and urodynamic parameters will be compared at baseline and 4 weeks&#xD;
      after BoNT-A injection within and between the treatment group and control groups. For the&#xD;
      patients who do not have significant improvement 4 weeks after BoNT-A injections, a second&#xD;
      injection with 100 units of BoNT-A will be performed at 4 weeks after the initial injection&#xD;
      regardless the patient's initial grouping. These patients will be followed up at the same&#xD;
      interval until the return of voiding dysfunction.&#xD;
&#xD;
      Continuous variables are presented as means ± standard deviations (SDs), and categorical data&#xD;
      are presented as numbers and percentages (%). Statistical comparisons within group will be&#xD;
      performed by paired t test, between the groups are tested using the chi-square test for&#xD;
      categorical variables, and the Wilcoxon rank-sum test for continuous variables. Long-term&#xD;
      successful results are compared using Kaplan-Meier analyses. Statistical assessments are&#xD;
      considered significant when p &lt; 0.05. Statistical analyses will be performed using SPSS 15.0&#xD;
      statistical software (SPSS Inc., Chicago, IL).&#xD;
&#xD;
      Any side effect related to the BoNT-A injections will be asked to report. There has not been&#xD;
      reported to have serious side effect from local injection of BoNT-A to the urethral&#xD;
      sphincter. However, the potential side effects, such as exacerbation of urinary incontinence,&#xD;
      allergy and anaphylactic shock should be informed to the patients and carefully monitor the&#xD;
      postoperative conditions. Urinalysis will be checked at the first follow-up 1 and 2 week&#xD;
      after BoNT-A injection. Antibiotics will be given if patients have significant urinary tract&#xD;
      infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net change of Patient Perception of Bladder Condition (PPBC)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of Patient Perception of Bladder Condition (PPBC) at baseline and 4 weeks after the initial injection. If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Net change of the quality of life score</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the quality of life score at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Quality of life score which are adopted from the International Prostate Symptom Score (IPSS) system.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the maximal urethral closure pressure (MUCP)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the maximal urethral closure pressure (MUCP) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the functional profile length (FPL)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the functional profile length (FPL) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the cystometric bladder capacity (CBC)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of cystometric bladder capacity (CBC) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the bladder compliance</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the bladder compliance at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the voiding detrusor pressure (Pdet)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the voiding detrusor pressure (Pdet) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the maximal flow rate (Qmax)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the voided volume</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the voided volume at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net change of the postvoid residual urine volume (PVR)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Efficacy:&#xD;
Efficacy measured the net change of the residual urine volume (PVR) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.&#xD;
Safety:&#xD;
Systemic adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Dysfunctional Voiding</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm-Normal saline instillation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline instillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin A</intervention_name>
    <description>A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.</description>
    <arm_group_label>Botulinum toxin A</arm_group_label>
    <other_name>Botulinum Toxin A (BoNT-A)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline instillation</intervention_name>
    <description>Normal saline instillation</description>
    <arm_group_label>Control arm-Normal saline instillation</arm_group_label>
    <other_name>N/S</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with age of 20 years old or above.&#xD;
&#xD;
          -  Free of active urinary tract infection.&#xD;
&#xD;
          -  Free of bladder outlet obstruction on enrollment.&#xD;
&#xD;
          -  Patients should have severe dysuria or urinary retention, large residual urine and&#xD;
             have been treated with medication or other therapeutic modality for over 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe cardiopulmonary disease and such as congestive heart failure,&#xD;
             arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.&#xD;
&#xD;
          -  Patients with bladder outlet obstruction on enrollment.&#xD;
&#xD;
          -  Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.&#xD;
&#xD;
          -  Patients have laboratory abnormalities at screening including: Alanine&#xD;
             aminotransferase (ALT) &gt; 3 x upper limit of normal range aspartate aminotransferase&#xD;
             (AST) &gt; 3 x upper limit of normal range.&#xD;
&#xD;
          -  Patients have abnormal serum creatinine level &gt; 2 x upper limit of normal range.&#xD;
&#xD;
          -  Patients with any contraindication to be urethral catheterization during treatment.&#xD;
&#xD;
          -  Female patients who is pregnant, lactating, or with child-bearing potential without&#xD;
             contraception.&#xD;
&#xD;
          -  Patients with any other serious disease considered by the investigator not suitable&#xD;
             for general anesthesia or in the condition to enter the trial.&#xD;
&#xD;
          -  Patients participated investigational drug trial within 1 month before entering this&#xD;
             study.&#xD;
&#xD;
          -  Written informed consent has been obtained.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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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    <PMID>4039484</PMID>
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  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 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>Botulinum Toxin A (BoNT-A)</keyword>
  <keyword>Dysfunctional voiding</keyword>
  <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>
  <!-- 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/NCT01733290
org study id: TCGHUROL006
nct id: NCT01733290
lead sponsor: 
has dmc: No
This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients
      with dysfunctional voiding. The results of this study can provide further information for
      patient selection and therapeutic duration.
This study is designed in a randomized, double-blind, placebo controlled, multicentric trial.
      A total of 60 patients will be enrolled. All patients have suffered from dysfunctional
      voiding that is refractory to conventional treatment. The enrolled patients should have
      severe dysuria or urinary retention, large residual urine and have been treated with
      medication or other therapeutic modality for over 3 months. The patients will be randomly
      assigned to allocate in the treatment and control groups in a 2:1 ratio. About 40 and 20
      patients will be enrolled in the treatment and control group, respectively.

      This study should be approved by the Institutional Review Board (IRB) and ethical committee
      of the hospital. Every patient should be thoroughly informed and written informed consent
      should be obtained before treatment.

      Patients will receive a complete urological work-up before treatment, including urinalysis,
      urine culture, cystoscopy to prove no anatomical stricture or lower urinary tract pathology,
      and videourodynamic study. All medication that may affect the lower urinary tract function
      will be stopped at least 1 week before Botulinum Toxin A (BoNT-A) injection.

      Videourodynamic study will be performed with the patient in supine position if patients
      cannot stand up or sit on the commode. A 6 Fr dual channel urethral pressure profiles (UPP)
      urethral catheter will be inserted to the urinary bladder. After evacuation of the residual
      urine, urethral pressure profilometry will be performed first. Then the bladder will be
      filled with normal saline containing 20% urografin at the filling rate of 30 ml/min. The
      filling and voiding cystourethrography will be investigated by a C-arm positioned below the
      patient. Uroflowmetry is recorded by a weighed transducer placed below the examination table.
      After the bladder is filled to the capacity, the patients are asked to urinate per urethrae.
      If patient cannot urinate per urethrae with the urethral catheter in situ, suprapubic
      puncture with a 18 Gauge needle and a 3-Fr epidural catheter will be undertaken and patients
      will urinate without the catheter in the urethra. The patients are requested to stand up and
      urinate into the commode. Pressure flow study and concomitant voiding cystourethrography are
      performed.

      The urodynamic parameters include maximal urethral closure pressure (MUCP), functional
      profile length (FPL), cystometric bladder capacity (CBC), bladder compliance, voiding
      detrusor pressure (Pdet), maximal flow rate (Qmax), voided volume, and postvoid residual
      urine volume (PVR). In the patients who have detrusor underactivity, the abdominal pressure
      to urinate and the detrusor leak point pressure will be measured. Images of voiding
      cystourethrography will be emphasized on the bladder neck opening, urethral sphincter
      relaxation, and dilatation of posterior urethra during voiding.

      Patients will be admitted and BoNT-A (treatment group) or normal saline (control group)
      injections will be performed in the operation room where complete cardiovascular monitoring
      is available during the operation. BoNT-A injections are made under cystoscopy guide in male
      patients and injecting periurethrally in female patients. The BoNT-A will be purchased from
      Allergan Company (Botox, 100 units/vial, Irvine, California, U.S.A.). Each vial of BoNT-A
      will be diluted to 5 ml by normal saline. A total of 100 units of BoNT-A will be injected
      deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate
      equal aliquot. After BoNT-A injections, a 14 Fr Foley catheter will be indwelled routinely
      for 1 day and then removed. Patients will be followed up for their voiding conditions. When
      dysuria persists, intermittent catheterization will be advised instead of indwelling Foley
      catheter. Antibiotics will not be necessary unless urinary tract infection occurs, and
      medications to reduce urethral sphincteric resistance are discontinued.

      Patients will be closely contacted and monitored by the research assistant by telephone. They
      will be followed up at out-patient clinic at 1 week, 2 weeks and 4 weeks after BoNT-A
      injections. After the first month after initial BoNT-A injection, patients will be followed
      up monthly until the therapeutic effect is gone. Videourodynamic study and UPP study will be
      performed at 4 weeks after BoNT-A injections. The subjective improvement of voiding condition
      will be assessed by the obstructive symptom scores (including hesitancy, intermittency,
      dysuria, small caliber of urine) and quality of life score which are adopted from the
      International Prostate Symptom Score (IPSS) system.

      The primary end-point is the change of Patient Perception of Bladder Condition (PPBC) at 4
      weeks after the initial injection. If patients have a PPBC improved by two scales, they are
      considered as successfully treated, otherwise failed treatment. The subjective symptom score,
      quality of life score and urodynamic parameters will be compared at baseline and 4 weeks
      after BoNT-A injection within and between the treatment group and control groups. For the
      patients who do not have significant improvement 4 weeks after BoNT-A injections, a second
      injection with 100 units of BoNT-A will be performed at 4 weeks after the initial injection
      regardless the patient's initial grouping. These patients will be followed up at the same
      interval until the return of voiding dysfunction.

      Continuous variables are presented as means ± standard deviations (SDs), and categorical data
      are presented as numbers and percentages (%). Statistical comparisons within group will be
      performed by paired t test, between the groups are tested using the chi-square test for
      categorical variables, and the Wilcoxon rank-sum test for continuous variables. Long-term
      successful results are compared using Kaplan-Meier analyses. Statistical assessments are
      considered significant when p < 0.05. Statistical analyses will be performed using SPSS 15.0
      statistical software (SPSS Inc., Chicago, IL).

      Any side effect related to the BoNT-A injections will be asked to report. There has not been
      reported to have serious side effect from local injection of BoNT-A to the urethral
      sphincter. However, the potential side effects, such as exacerbation of urinary incontinence,
      allergy and anaphylactic shock should be informed to the patients and carefully monitor the
      postoperative conditions. Urinalysis will be checked at the first follow-up 1 and 2 week
      after BoNT-A injection. Antibiotics will be given if patients have significant urinary tract
      infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Net change of Patient Perception of Bladder Condition (PPBC)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of Patient Perception of Bladder Condition (PPBC) at baseline and 4 weeks after the initial injection. If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment.
Safety:
Systemic adverse events
measure: Net change of the quality of life score
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the quality of life score at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Quality of life score which are adopted from the International Prostate Symptom Score (IPSS) system.
Safety:
Systemic adverse events
measure: Net change of the maximal urethral closure pressure (MUCP)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the maximal urethral closure pressure (MUCP) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the functional profile length (FPL)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the functional profile length (FPL) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the cystometric bladder capacity (CBC)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of cystometric bladder capacity (CBC) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the bladder compliance
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the bladder compliance at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the voiding detrusor pressure (Pdet)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the voiding detrusor pressure (Pdet) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the maximal flow rate (Qmax)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the voided volume
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the voided volume at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
measure: Net change of the postvoid residual urine volume (PVR)
time frame: Baseline and 4 weeks
description: Efficacy:
Efficacy measured the net change of the residual urine volume (PVR) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
arm group label: Botulinum toxin A
arm group type: Experimental
description: A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.
arm group label: Control arm-Normal saline instillation
arm group type: Placebo Comparator
description: Normal saline instillation
intervention type: Drug
intervention name: Botulinum toxin A
description: A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.
arm group label: Botulinum toxin A
other name: Botulinum Toxin A (BoNT-A)
intervention type: Drug
intervention name: Normal saline instillation
description: Normal saline instillation
arm group label: Control arm-Normal saline instillation
other name: N/S
criteria: 
gender: All
minimum age: 20 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: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA