<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/NCT01661621</url>
  </required_header>
  <id_info>
    <org_study_id>TCGHUROL002</org_study_id>
    <nct_id>NCT01661621</nct_id>
  </id_info>
  <brief_title>Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1</brief_title>
  <official_title>Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers</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 a prospective randomized, open label, controlled, double arm, post-marketing&#xD;
      study to compare the treatment efficacy of first-line antimuscarinics and α-blockers&#xD;
      monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)&#xD;
      (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio&#xD;
      (IPSS-V/S) ≤1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. STUDY PROCEDURE&#xD;
&#xD;
      1.1.General Study Design This study is a prospective randomized, open label, controlled,&#xD;
      double arm, post-marketing study to compare the treatment efficacy of first-line&#xD;
      antimuscarinics and α-blockers monotherapy for men with moderate to severe LUTS (IPSS-T ≥8)&#xD;
      and IPSS-V/S ≤1.&#xD;
&#xD;
      1.2. Study Visits and Evaluations&#xD;
&#xD;
      1.2.1 Screening Visit (Baseline, 1 day to 1 week of the first treatment day).&#xD;
&#xD;
      1.2.1.1 Explain the nature of the study and have patients to read and sign an Informed&#xD;
      Consent Form.&#xD;
&#xD;
      1.2.1.2 Screen patients for inclusion/exclusion criteria. 1.2.1.3 Medical History of lower&#xD;
      urinary tract symptoms and previous treatment modalities.&#xD;
&#xD;
      1.2.1.4 Vital signs monitoring, general physical examinations of all systems (including&#xD;
      digital rectal examination), serum prostatic specific antigen (PSA), and urinalysis.&#xD;
&#xD;
      1.2.1.5 Record Patient Perception of Bladder Condition (PPBC), IPSS (IPSS-T, IPSS voiding&#xD;
      (IPSS-V), and IPSS storage (IPSS-S)), Overactive Bladder Symptom Score (OAB-SS), and quality&#xD;
      of Life index (QoL-I)scores.&#xD;
&#xD;
      1.2.1.6 Obtain maximum flow rate (Qmax), voided volume, postvoid residual volume (PVR), total&#xD;
      prostate volume (TPV), and transitional zone index (TZI).&#xD;
&#xD;
      1.2.1.7 Randomized assigned patients into 2 groups; men in one group received Doxazosin 4 mg&#xD;
      QD, and those in the other group received Detrusitol 4 mg QD.&#xD;
&#xD;
      1.2.2 First Evaluation Visit (2 weeks after the initial treatment) 1.2.2.1 Vital signs&#xD;
      monitoring and record adverse events. 1.2.2.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S),&#xD;
      OAB-SS and QoL. 1.2.2.3 Check urinalysis for urinary tract infection if patient has symptoms&#xD;
      suggestive of urinary tract infection.&#xD;
&#xD;
      1.2.2.4 Check Qmax, voided volume, and PVR.&#xD;
&#xD;
      1.2.3 Second Evaluation Visit (4 weeks after the treatment). 1.2.3.1 Vital signs monitoring&#xD;
      and record adverse events. 1.2.3.3 Check urinalysis for urinary tract infection if patient&#xD;
      has symptoms suggestive of urinary tract infection.&#xD;
&#xD;
      1.2.3.4 Check Qmax, voided volume, and PVR.&#xD;
&#xD;
      1.2.4 Third Evaluation Visit (3 months after the treatment). 1.2.4.1 Vital signs monitoring&#xD;
      and record adverse events. 1.2.4.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S), OAB-SS and&#xD;
      QoL. 1.2.4.3 Check urinalysis for urinary tract infection if patient has symptoms suggestive&#xD;
      of urinary tract infection.&#xD;
&#xD;
      1.2.4.4 Check Qmax, voided volume, and PVR.&#xD;
&#xD;
      1.3. Withdrawal Criteria&#xD;
&#xD;
      Patients with any of the following conditions may be withdrawn from the trial:&#xD;
&#xD;
      1.3.1. Patients decide to withdraw their consent. 1.3.2. Patients indicate the status of lack&#xD;
      of efficacy which is of clinical significance judged by the investigators that may lead to&#xD;
      permanent damage to the patients.&#xD;
&#xD;
      1.3.3. Investigators consider that there is of safety concerns for the patients to remain in&#xD;
      the trial (such as development severe medical disease).&#xD;
&#xD;
      1.3.4. Lost of follow-up or death. 1.3.5. PVR≥300 mL&#xD;
&#xD;
      1.4. Concomitant Treatments Investigator will try to minimize the concomitant medications for&#xD;
      the patients during the trial duration. However, patients are allowed to continue taking&#xD;
      stable medication in stable dose for diseases other than genitourinary system.&#xD;
&#xD;
      1.5. Prohibited medication&#xD;
&#xD;
      Patients are not allowed to take any of the following medications during the study:&#xD;
&#xD;
        1. Anticholinergics other than test drug&#xD;
&#xD;
        2. Alpha-adrenergic receptor blockers&#xD;
&#xD;
        3. Tricyclic anti-depressants&#xD;
&#xD;
        4. Calcium channel blockers&#xD;
&#xD;
        5. Skeletal muscle relaxant&#xD;
&#xD;
        6. Cyclooxygenase-2 (COX-2) inhibitors&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Global Response Assessment (GRA) After the Treatment Day</measure>
    <time_frame>1 month after initial treatment</time_frame>
    <description>Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The global response assessment on a 6-point scale ranging from 1 &quot;No problems at all&quot; to 6 &quot;Many severe problems&quot;.&#xD;
Changes of the global response assessment (GRA) improved or reduction by 1 points.&#xD;
Change = Baseline minus Month 1 value&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Maximum Flow Rate (Qmax) After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Voided Volume After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Postvoid Residual Volume (PVR) After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Efficacy:&#xD;
Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The IPSS quality of life question score on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;.&#xD;
IPSS-QoL ranges 0 to 6 (Delighted to Terrible)&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">395</enrollment>
  <condition>Bladder Outlet Obstruction</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Antimuscarinics (Detrusitol 4 mg QD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>α-blockers (Doxazosin 4 mg QD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Detrusitol 4 mg QD</intervention_name>
    <description>Group 1</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxazosin 4 mg QD</intervention_name>
    <description>Group 2</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8)&#xD;
&#xD;
          -  Patient or his/her legally acceptable representative has signed the written informed&#xD;
             consent form&#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 urinary retention, urodynamically proven detrusor underactivity or PVR&#xD;
             ≥250 mL&#xD;
&#xD;
          -  Patients with known active urinary tract infection, urinary stone or malignancy&#xD;
&#xD;
          -  Patients with history of urethral injury or transurethral surgery for prostate or&#xD;
             bladder&#xD;
&#xD;
          -  Patients have laboratory abnormalities at screening including:&#xD;
&#xD;
               1. Aspartate aminotransferase (AST) &gt;3 x upper limit of normal range&#xD;
&#xD;
               2. Alanine aminotransferase (ALT) &gt;3 x upper limit of normal range&#xD;
&#xD;
               3. Patients have abnormal serum creatinine level &gt;2 x upper limit of normal range&#xD;
&#xD;
          -  Patients with any other serious disease or condition considered by the investigator&#xD;
             not suitable for entry into the trial&#xD;
&#xD;
          -  Patients participated investigational drug trial within 1 month before entering this&#xD;
             study&#xD;
&#xD;
          -  Patients with major psychiatric illness or drug abuse&#xD;
&#xD;
          -  Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase&#xD;
             (5AR) inhibitor within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</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>
  <reference>
    <citation>Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.</citation>
    <PMID>11857671</PMID>
  </reference>
  <reference>
    <citation>Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.</citation>
    <PMID>16530611</PMID>
  </reference>
  <reference>
    <citation>Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun;169(6):2253-6. doi: 10.1097/01.ju.0000067541.73285.eb.</citation>
    <PMID>12771763</PMID>
  </reference>
  <reference>
    <citation>Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.</citation>
    <PMID>15476515</PMID>
  </reference>
  <reference>
    <citation>Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319. Erratum In: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.</citation>
    <PMID>17105794</PMID>
  </reference>
  <reference>
    <citation>Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.</citation>
    <PMID>19837435</PMID>
  </reference>
  <reference>
    <citation>Chung DE, Te AE, Staskin DR, Kaplan SA. Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates &gt;30 grams. Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.</citation>
    <PMID>20206978</PMID>
  </reference>
  <reference>
    <citation>Chung SD, Chang HC, Chiu B, Liao CH, Kuo HC. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Neurourol Urodyn. 2011 Apr;30(4):568-71. doi: 10.1002/nau.20923. Epub 2011 Feb 22.</citation>
    <PMID>21344494</PMID>
  </reference>
  <reference>
    <citation>Blake-James BT, Rashidian A, Ikeda Y, Emberton M. The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis. BJU Int. 2007 Jan;99(1):85-96. doi: 10.1111/j.1464-410X.2006.06574.x. Epub 2006 Oct 9.</citation>
    <PMID>17026588</PMID>
  </reference>
  <reference>
    <citation>Martin-Merino E, Garcia-Rodriguez LA, Masso-Gonzalez EL, Roehrborn CG. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? J Urol. 2009 Oct;182(4):1442-8. doi: 10.1016/j.juro.2009.06.051. Epub 2009 Aug 15.</citation>
    <PMID>19683302</PMID>
  </reference>
  <reference>
    <citation>McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.</citation>
    <PMID>21420124</PMID>
  </reference>
  <reference>
    <citation>Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef.</citation>
    <PMID>21045704</PMID>
  </reference>
  <reference>
    <citation>Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011 Apr;65(4):487-507. doi: 10.1111/j.1742-1241.2010.02611.x. Epub 2011 Jan 7.</citation>
    <PMID>21210910</PMID>
  </reference>
  <reference>
    <citation>Athanasopoulos A, Chapple C, Fowler C, Gratzke C, Kaplan S, Stief C, Tubaro A. The role of antimuscarinics in the management of men with symptoms of overactive bladder associated with concomitant bladder outlet obstruction: an update. Eur Urol. 2011 Jul;60(1):94-105. doi: 10.1016/j.eururo.2011.03.054. Epub 2011 Apr 9.</citation>
    <PMID>21497434</PMID>
  </reference>
  <reference>
    <citation>Chapple C. Antimuscarinics in men with lower urinary tract symptoms suggestive of bladder outlet obstruction due to benign prostatic hyperplasia. Curr Opin Urol. 2010 Jan;20(1):43-8. doi: 10.1097/MOU.0b013e3283330862.</citation>
    <PMID>19875964</PMID>
  </reference>
  <reference>
    <citation>Liao CH, Chung SD, Kuo HC. Diagnostic value of International Prostate Symptom Score voiding-to-storage subscore ratio in male lower urinary tract symptoms. Int J Clin Pract. 2011 May;65(5):552-8. doi: 10.1111/j.1742-1241.2011.02638.x.</citation>
    <PMID>21489080</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>April 21, 2014</results_first_submitted>
  <results_first_submitted_qc>June 23, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 25, 2014</results_first_posted>
  <last_update_submitted>June 23, 2014</last_update_submitted>
  <last_update_submitted_qc>June 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2014</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>Department of Urology</investigator_title>
  </responsible_party>
  <keyword>Lower urinary tract symptoms (LUTS)</keyword>
  <keyword>International Prostate Symptom Score (IPSS)</keyword>
  <keyword>Antimuscarinics</keyword>
  <keyword>α-blockers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neck Obstruction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxazosin</mesh_term>
    <mesh_term>Tolterodine Tartrate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="279"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="279"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="116"/>
            <count group_id="B2" value="279"/>
            <count group_id="B3" value="395"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.4" spread="11.3"/>
                    <measurement group_id="B2" value="65.6" spread="10.5"/>
                    <measurement group_id="B3" value="66.4" spread="10.8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="279"/>
                    <measurement group_id="B3" value="395"/>
                  </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="116"/>
                    <measurement group_id="B2" value="279"/>
                    <measurement group_id="B3" value="395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Global Response Assessment (GRA) After the Treatment Day</title>
        <description>Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The global response assessment on a 6-point scale ranging from 1 &quot;No problems at all&quot; to 6 &quot;Many severe problems&quot;.&#xD;
Changes of the global response assessment (GRA) improved or reduction by 1 points.&#xD;
Change = Baseline minus Month 1 value&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness</description>
        <time_frame>1 month after initial treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The Global Response Assessment (GRA) After the Treatment Day</title>
          <description>Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The global response assessment on a 6-point scale ranging from 1 &quot;No problems at all&quot; to 6 &quot;Many severe problems&quot;.&#xD;
Changes of the global response assessment (GRA) improved or reduction by 1 points.&#xD;
Change = Baseline minus Month 1 value&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GRA≥1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GRA&lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day</title>
        <description>Efficacy:&#xD;
Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day</title>
          <description>Efficacy:&#xD;
Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;.&#xD;
Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" spread="5.40"/>
                    <measurement group_id="O2" value="18.0" spread="6.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="6.81"/>
                    <measurement group_id="O2" value="10.8" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Maximum Flow Rate (Qmax) After the Treatment Day</title>
        <description>Efficacy:&#xD;
Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The Maximum Flow Rate (Qmax) After the Treatment Day</title>
          <description>Efficacy:&#xD;
Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="8.10"/>
                    <measurement group_id="O2" value="11.4" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="7.90"/>
                    <measurement group_id="O2" value="13.6" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Voided Volume After the Treatment Day</title>
        <description>Efficacy:&#xD;
Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The Voided Volume After the Treatment Day</title>
          <description>Efficacy:&#xD;
Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.5" spread="168.8"/>
                    <measurement group_id="O2" value="244.0" spread="148.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="231.6" spread="163.6"/>
                    <measurement group_id="O2" value="268.3" spread="150.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Postvoid Residual Volume (PVR) After the Treatment Day</title>
        <description>Efficacy:&#xD;
Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The Postvoid Residual Volume (PVR) After the Treatment Day</title>
          <description>Efficacy:&#xD;
Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.1" spread="62.6"/>
                    <measurement group_id="O2" value="53.9" spread="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.4" spread="60.4"/>
                    <measurement group_id="O2" value="42.9" spread="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day</title>
        <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day</title>
          <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.31" spread="3.51"/>
                    <measurement group_id="O2" value="12.3" spread="4.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="4.75"/>
                    <measurement group_id="O2" value="6.49" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day</title>
        <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day</title>
          <description>Efficacy:&#xD;
Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.&#xD;
The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 &quot;Not at all&quot; to 5 &quot;Almost always&quot;. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.&#xD;
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.51" spread="3.05"/>
                    <measurement group_id="O2" value="5.70" spread="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.40" spread="3.47"/>
                    <measurement group_id="O2" value="4.31" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day</title>
        <description>Efficacy:&#xD;
Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The IPSS quality of life question score on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;.&#xD;
IPSS-QoL ranges 0 to 6 (Delighted to Terrible)&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</description>
        <time_frame>Baseline and 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</description>
          </group>
        </group_list>
        <measure>
          <title>The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day</title>
          <description>Efficacy:&#xD;
Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.&#xD;
The IPSS quality of life question score on a 7-point scale ranging from 0 &quot;Delighted&quot; to 6 &quot;Terrible&quot;.&#xD;
IPSS-QoL ranges 0 to 6 (Delighted to Terrible)&#xD;
Safety:&#xD;
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness</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="116"/>
                <count group_id="O2" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="1.01"/>
                    <measurement group_id="O2" value="3.88" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread="1.18"/>
                    <measurement group_id="O2" value="2.82" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Antimuscarinics (Detrusitol 4 mg QD)&#xD;
Detrusitol 4 mg QD: Group 1</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>α-blockers (Doxazosin 4 mg QD)&#xD;
Doxazosin 4 mg QD: Group 2</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="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="279"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="18" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="279"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>General weakness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>Palpitation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="279"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="116"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="279"/>
              </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/NCT01661621
org study id: TCGHUROL002
nct id: NCT01661621
lead sponsor: 
has dmc: No
This study is a prospective randomized, open label, controlled, double arm, post-marketing
      study to compare the treatment efficacy of first-line antimuscarinics and α-blockers
      monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)
      (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio
      (IPSS-V/S) ≤1.
1. STUDY PROCEDURE

      1.1.General Study Design This study is a prospective randomized, open label, controlled,
      double arm, post-marketing study to compare the treatment efficacy of first-line
      antimuscarinics and α-blockers monotherapy for men with moderate to severe LUTS (IPSS-T ≥8)
      and IPSS-V/S ≤1.

      1.2. Study Visits and Evaluations

      1.2.1 Screening Visit (Baseline, 1 day to 1 week of the first treatment day).

      1.2.1.1 Explain the nature of the study and have patients to read and sign an Informed
      Consent Form.

      1.2.1.2 Screen patients for inclusion/exclusion criteria. 1.2.1.3 Medical History of lower
      urinary tract symptoms and previous treatment modalities.

      1.2.1.4 Vital signs monitoring, general physical examinations of all systems (including
      digital rectal examination), serum prostatic specific antigen (PSA), and urinalysis.

      1.2.1.5 Record Patient Perception of Bladder Condition (PPBC), IPSS (IPSS-T, IPSS voiding
      (IPSS-V), and IPSS storage (IPSS-S)), Overactive Bladder Symptom Score (OAB-SS), and quality
      of Life index (QoL-I)scores.

      1.2.1.6 Obtain maximum flow rate (Qmax), voided volume, postvoid residual volume (PVR), total
      prostate volume (TPV), and transitional zone index (TZI).

      1.2.1.7 Randomized assigned patients into 2 groups; men in one group received Doxazosin 4 mg
      QD, and those in the other group received Detrusitol 4 mg QD.

      1.2.2 First Evaluation Visit (2 weeks after the initial treatment) 1.2.2.1 Vital signs
      monitoring and record adverse events. 1.2.2.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S),
      OAB-SS and QoL. 1.2.2.3 Check urinalysis for urinary tract infection if patient has symptoms
      suggestive of urinary tract infection.

      1.2.2.4 Check Qmax, voided volume, and PVR.

      1.2.3 Second Evaluation Visit (4 weeks after the treatment). 1.2.3.1 Vital signs monitoring
      and record adverse events. 1.2.3.3 Check urinalysis for urinary tract infection if patient
      has symptoms suggestive of urinary tract infection.

      1.2.3.4 Check Qmax, voided volume, and PVR.

      1.2.4 Third Evaluation Visit (3 months after the treatment). 1.2.4.1 Vital signs monitoring
      and record adverse events. 1.2.4.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S), OAB-SS and
      QoL. 1.2.4.3 Check urinalysis for urinary tract infection if patient has symptoms suggestive
      of urinary tract infection.

      1.2.4.4 Check Qmax, voided volume, and PVR.

      1.3. Withdrawal Criteria

      Patients with any of the following conditions may be withdrawn from the trial:

      1.3.1. Patients decide to withdraw their consent. 1.3.2. Patients indicate the status of lack
      of efficacy which is of clinical significance judged by the investigators that may lead to
      permanent damage to the patients.

      1.3.3. Investigators consider that there is of safety concerns for the patients to remain in
      the trial (such as development severe medical disease).

      1.3.4. Lost of follow-up or death. 1.3.5. PVR≥300 mL

      1.4. Concomitant Treatments Investigator will try to minimize the concomitant medications for
      the patients during the trial duration. However, patients are allowed to continue taking
      stable medication in stable dose for diseases other than genitourinary system.

      1.5. Prohibited medication

      Patients are not allowed to take any of the following medications during the study:

        1. Anticholinergics other than test drug

        2. Alpha-adrenergic receptor blockers

        3. Tricyclic anti-depressants

        4. Calcium channel blockers

        5. Skeletal muscle relaxant

        6. Cyclooxygenase-2 (COX-2) inhibitors
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Global Response Assessment (GRA) After the Treatment Day
time frame: 1 month after initial treatment
description: Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.
The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems".
Changes of the global response assessment (GRA) improved or reduction by 1 points.
Change = Baseline minus Month 1 value
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
measure: The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always".
Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The Maximum Flow Rate (Qmax) After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The Voided Volume After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The Postvoid Residual Volume (PVR) After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.
The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.
The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
measure: The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day
time frame: Baseline and 1 month
description: Efficacy:
Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.
The IPSS quality of life question score on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible".
IPSS-QoL ranges 0 to 6 (Delighted to Terrible)
Safety:
Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness
arm group label: Group 1
arm group type: Experimental
description: Antimuscarinics (Detrusitol 4 mg QD)
arm group label: Group 2
arm group type: Experimental
description: α-blockers (Doxazosin 4 mg QD)
intervention type: Drug
intervention name: Detrusitol 4 mg QD
description: Group 1
arm group label: Group 1
intervention type: Drug
intervention name: Doxazosin 4 mg QD
description: Group 2
arm group label: Group 2
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
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
citation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PMID: 11857671
citation: Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.
PMID: 16530611
citation: Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun;169(6):2253-6. doi: 10.1097/01.ju.0000067541.73285.eb.
PMID: 12771763
citation: Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.
PMID: 15476515
citation: Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319. Erratum In: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.
PMID: 17105794
citation: Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
PMID: 19837435
citation: Chung DE, Te AE, Staskin DR, Kaplan SA. Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams. Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.
PMID: 20206978
citation: Chung SD, Chang HC, Chiu B, Liao CH, Kuo HC. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Neurourol Urodyn. 2011 Apr;30(4):568-71. doi: 10.1002/nau.20923. Epub 2011 Feb 22.
PMID: 21344494
citation: Blake-James BT, Rashidian A, Ikeda Y, Emberton M. The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis. BJU Int. 2007 Jan;99(1):85-96. doi: 10.1111/j.1464-410X.2006.06574.x. Epub 2006 Oct 9.
PMID: 17026588
citation: Martin-Merino E, Garcia-Rodriguez LA, Masso-Gonzalez EL, Roehrborn CG. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? J Urol. 2009 Oct;182(4):1442-8. doi: 10.1016/j.juro.2009.06.051. Epub 2009 Aug 15.
PMID: 19683302
citation: McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
PMID: 21420124
citation: Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef.
PMID: 21045704
citation: Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011 Apr;65(4):487-507. doi: 10.1111/j.1742-1241.2010.02611.x. Epub 2011 Jan 7.
PMID: 21210910
citation: Athanasopoulos A, Chapple C, Fowler C, Gratzke C, Kaplan S, Stief C, Tubaro A. The role of antimuscarinics in the management of men with symptoms of overactive bladder associated with concomitant bladder outlet obstruction: an update. Eur Urol. 2011 Jul;60(1):94-105. doi: 10.1016/j.eururo.2011.03.054. Epub 2011 Apr 9.
PMID: 21497434
citation: Chapple C. Antimuscarinics in men with lower urinary tract symptoms suggestive of bladder outlet obstruction due to benign prostatic hyperplasia. Curr Opin Urol. 2010 Jan;20(1):43-8. doi: 10.1097/MOU.0b013e3283330862.
PMID: 19875964
citation: Liao CH, Chung SD, Kuo HC. Diagnostic value of International Prostate Symptom Score voiding-to-storage subscore ratio in male lower urinary tract symptoms. Int J Clin Pract. 2011 May;65(5):552-8. doi: 10.1111/j.1742-1241.2011.02638.x.
PMID: 21489080
responsible party type: Principal Investigator
investigator affiliation: Buddhist Tzu Chi General Hospital
investigator full name: Hann-Chorng Kuo
investigator title: Department of Urology
mesh term: Urinary Bladder Neck Obstruction
mesh term: Doxazosin
mesh term: Tolterodine Tartrate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 