xml: <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/NCT06020963</url>
    </required_header>
    <id_info>
      <org_study_id>A202205205</org_study_id>
      <nct_id>NCT06020963</nct_id>
    </id_info>
    <brief_title>Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.</brief_title>
    <official_title>Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taichung Armed Forces General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taichung Armed Forces General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With the increasing of the elderly population, patients with urinary dysfunction caused by&#xD;
        inefficiency of bladder emptying becomes much often than before. However, the current&#xD;
        treatments for this kind of bladder dysfunction are limited and unsatisfactory. Low-intensity&#xD;
        extracorporeal shockwave therapy (LiESWT) is a very popular emerging treatment in recent&#xD;
        years, and abundant of literatures have confirmed that this treatment is safe and effective&#xD;
        in myofascial pain and male erectile dysfunction. Recently, many animal experiments have&#xD;
        showed that LiESWT could improve urinary dysfunction caused by bladder dysfunction. Taiwan&#xD;
        based studies also reported that LiESWT could improve symptoms of overactive bladder. LiESWT&#xD;
        is a non-drug, low-invasive and high-safety treatment, which is very suitable for elderly&#xD;
        patients. In this study we combine the LiESWT and acupuncture to treat the patients with&#xD;
        underactive bladder. We hypothesize that LiESWT could improve bladder voiding efficiency.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized controlled trial, the inclusion criteria are the patients more than 20&#xD;
        years old and bladder voiding efficiency less than 70%, we will enroll 60 male and 40 female&#xD;
        , total 100 patients. The male will be randomly assigned into three groups(Group-1, Group-2,&#xD;
        Group-3) by ratio 1:1:1, and the female will be randomly assigned into two groups (Group-1,&#xD;
        Group-2) by ratio 1:1. Group-1: LiESWT on acupoint CV-4, and bilateral ST-28 once a week for&#xD;
        8 weeks, Group-2: LiESWT on acupoint CV-4 and bilateral acupoint SP-6 once a week for 8&#xD;
        weeks, Group-3: Treatment with oral tamsulosin 0.2mg per-day for 8 weeks. The primary outcome&#xD;
        is the improvement of bladder voiding efficiency. The secondary outcomes are global response&#xD;
        assessment scale, the improvement of maximum uroflow rate, post-voiding residual urine&#xD;
        amount, total score of international prostate symptom score.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Evaluate the treatment effect of Low-intensity shockwave therapy on acupoint (CV-4, ST-28, SP-6 once a week for 8 weeks) and the control group is oral tamsulosin 0.2mg daily for 8 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bladder Voiding Efficiency (BVE)</measure>
      <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
      <description>Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Global Response Assessment scale</measure>
      <time_frame>Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.</time_frame>
      <description>GRA is a scale for subjective evaluation of treatment effects by patients, ranging from the worst -3 points to the best 3 points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum uroflow rate</measure>
      <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
      <description>The maximum uroflow rate during voiding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-Voiding Residual urine amount</measure>
      <time_frame>Baseline, Week 4, Week 8, Week 12</time_frame>
      <description>Post-Voiding Residual urine amount is the residual urine in bladder after voiding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total score of international prostate symptom score</measure>
      <time_frame>Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.</time_frame>
      <description>International prostate symptom score is a questionnaire used to assess the severity of lower urinary tract symptoms, ranging from best 0, to the worst 35.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Detrusor Underactivity</condition>
    <arm_group>
      <arm_group_label>Group-1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-3</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Oral tamsulosin 0.2mg once daily for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Low Intensity Shockwave Therapy (LiSWT)</intervention_name>
      <description>Low Intensity Shockwave Therapy (LiSWT) has been used for many years. Its mechanism is to use shock wave energy to promote angiogenesis to achieve the functions of tissue repair and cell regeneration.</description>
      <arm_group_label>Group-1</arm_group_label>
      <arm_group_label>Group-2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tamsulosin</intervention_name>
      <description>Tamsulosin is a selective alpha-1 blocker, its main function is to relax the smooth muscles of the base of the prostate, urethra, and bladder, and improve lower urinary tract symptoms.</description>
      <arm_group_label>Group-3</arm_group_label>
      <other_name>Harnalidge 0.2mg</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient who aged over 20 years old and who's bladder voiding efficiency is less&#xD;
               than 70%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Active pelvic malignancy without treatment. 2. Acute urinary tract infection. 3.&#xD;
               Pregnancy 4. Active infection on treatment site. 5. Open wound on treatment site.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jing-Dung Shen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taichung Armed Forces General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jing-Dung Shen, MD</last_name>
      <phone>+886958878129</phone>
      <email>jdwhydo@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taichung Armed Forces General Hospital</name>
        <address>
          <city>Taichung</city>
          <state>Other (Non US)</state>
          <zip>41168</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jing-dung Shen, MD</last_name>
        <phone>+886958878129</phone>
        <email>jdwhydo@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Jing-dung Shen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <reference>
      <citation>Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12.</citation>
      <PMID>32523286</PMID>
    </reference>
    <reference>
      <citation>Lee YC, Hsieh TJ, Tang FH, Jhan JH, Lin KL, Juan YS, Wang HS, Long CY. Therapeutic effect of Low intensity Extracorporeal Shock Wave Therapy (Li-ESWT) on diabetic bladder dysfunction in a rat model. Int J Med Sci. 2021 Jan 29;18(6):1423-1431. doi: 10.7150/ijms.55274. eCollection 2021.</citation>
      <PMID>33628099</PMID>
    </reference>
    <reference>
      <citation>Wang HS, Oh BS, Wang B, Ruan Y, Zhou J, Banie L, Lee YC, Tamaddon A, Zhou T, Wang G, Lin G, Lue TF. Low-intensity extracorporeal shockwave therapy ameliorates diabetic underactive bladder in streptozotocin-induced diabetic rats. BJU Int. 2018 Sep;122(3):490-500. doi: 10.1111/bju.14216. Epub 2018 Apr 20.</citation>
      <PMID>29603534</PMID>
    </reference>
    <reference>
      <citation>Dimitriadis F, Papaioannou M, Sokolakis I, Fragou A, Hatzichristou D, Apostolidis A. The Effect of Low-Intensity Extracorporeal Shockwave Treatment on the Urinary Bladder in an Experimental Diabetic Rat Model. Int Neurourol J. 2021 Mar;25(1):34-41. doi: 10.5213/inj.2040344.172. Epub 2021 Mar 6.</citation>
      <PMID>33676379</PMID>
    </reference>
    <reference>
      <citation>Chuang YC, Tyagi P, Luo HL, Lee WC, Wang HJ, Huang CC, Chancellor MB. Long-term functional change of cryoinjury-induced detrusor underactivity and effects of extracorporeal shock wave therapy in a rat model. Int Urol Nephrol. 2019 Apr;51(4):617-626. doi: 10.1007/s11255-019-02095-4. Epub 2019 Feb 22.</citation>
      <PMID>30796726</PMID>
    </reference>
    <reference>
      <citation>Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2.</citation>
      <PMID>28767169</PMID>
    </reference>
    <reference>
      <citation>Yoshida M, Sekido N, Matsukawa Y, Yono M, Yamaguchi O. Clinical diagnostic criteria for detrusor underactivity: A report from the Japanese Continence Society working group on underactive bladder. Low Urin Tract Symptoms. 2021 Jan;13(1):13-16. doi: 10.1111/luts.12356. Epub 2020 Oct 7.</citation>
      <PMID>33029933</PMID>
    </reference>
    <reference>
      <citation>Lin KL, Lu JH, Chueh KS, Juan TJ, Wu BN, Chuang SM, Lee YC, Shen MC, Long CY, Juan YS. Low-Intensity Extracorporeal Shock Wave Therapy Promotes Bladder Regeneration and Improves Overactive Bladder Induced by Ovarian Hormone Deficiency from Rat Animal Model to Human Clinical Trial. Int J Mol Sci. 2021 Aug 27;22(17):9296. doi: 10.3390/ijms22179296.</citation>
      <PMID>34502202</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taichung Armed Forces General Hospital</investigator_affiliation>
      <investigator_full_name>Jing-Dung, SHEN</investigator_full_name>
      <investigator_title>Director of Urology</investigator_title>
    </responsible_party>
    <keyword>detrusor underactivity</keyword>
    <keyword>acupoint</keyword>
    <keyword>voiding dysfunction</keyword>
    <keyword>bladder voiding efficiency</keyword>
    <keyword>low-intensity extracorporeal shockwave therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypokinesia</mesh_term>
      <mesh_term>Urinary Bladder, Underactive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tamsulosin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020963
  org study id: A202205205
  nct id: NCT06020963
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  With the increasing of the elderly population, patients with urinary dysfunction caused by
        inefficiency of bladder emptying becomes much often than before. However, the current
        treatments for this kind of bladder dysfunction are limited and unsatisfactory. Low-intensity
        extracorporeal shockwave therapy (LiESWT) is a very popular emerging treatment in recent
        years, and abundant of literatures have confirmed that this treatment is safe and effective
        in myofascial pain and male erectile dysfunction. Recently, many animal experiments have
        showed that LiESWT could improve urinary dysfunction caused by bladder dysfunction. Taiwan
        based studies also reported that LiESWT could improve symptoms of overactive bladder. LiESWT
        is a non-drug, low-invasive and high-safety treatment, which is very suitable for elderly
        patients. In this study we combine the LiESWT and acupuncture to treat the patients with
        underactive bladder. We hypothesize that LiESWT could improve bladder voiding efficiency.
  This is a randomized controlled trial, the inclusion criteria are the patients more than 20
        years old and bladder voiding efficiency less than 70%, we will enroll 60 male and 40 female
        , total 100 patients. The male will be randomly assigned into three groups(Group-1, Group-2,
        Group-3) by ratio 1:1:1, and the female will be randomly assigned into two groups (Group-1,
        Group-2) by ratio 1:1. Group-1: LiESWT on acupoint CV-4, and bilateral ST-28 once a week for
        8 weeks, Group-2: LiESWT on acupoint CV-4 and bilateral acupoint SP-6 once a week for 8
        weeks, Group-3: Treatment with oral tamsulosin 0.2mg per-day for 8 weeks. The primary outcome
        is the improvement of bladder voiding efficiency. The secondary outcomes are global response
        assessment scale, the improvement of maximum uroflow rate, post-voiding residual urine
        amount, total score of international prostate symptom score.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Evaluate the treatment effect of Low-intensity shockwave therapy on acupoint (CV-4, ST-28, SP-6 once a week for 8 weeks) and the control group is oral tamsulosin 0.2mg daily for 8 weeks.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Bladder Voiding Efficiency (BVE)
  time frame: Baseline, Week 4, Week 8, Week 12
  description: Bladder Voiding Efficiency (BVE) is the ratio of the voiding volume of urine over total bladder urine volume
  measure: Global Response Assessment scale
  time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
  description: GRA is a scale for subjective evaluation of treatment effects by patients, ranging from the worst -3 points to the best 3 points
  measure: Maximum uroflow rate
  time frame: Baseline, Week 4, Week 8, Week 12
  description: The maximum uroflow rate during voiding.
  measure: Post-Voiding Residual urine amount
  time frame: Baseline, Week 4, Week 8, Week 12
  description: Post-Voiding Residual urine amount is the residual urine in bladder after voiding.
  measure: Total score of international prostate symptom score
  time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12.
  description: International prostate symptom score is a questionnaire used to assess the severity of lower urinary tract symptoms, ranging from best 0, to the worst 35.
  arm group label: Group-1
  arm group type: Experimental
  description: Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral ST-28) once a week for 8 weeks.
  arm group label: Group-2
  arm group type: Experimental
  description: Low intensive shockwave therapy 1000 shocks on each acupoint (CV-4, and bilateral SP-6) once a week for 8 weeks.
  arm group label: Group-3
  arm group type: Active Comparator
  description: Oral tamsulosin 0.2mg once daily for 8 weeks.
  intervention type: Procedure
  intervention name: Low Intensity Shockwave Therapy (LiSWT)
  description: Low Intensity Shockwave Therapy (LiSWT) has been used for many years. Its mechanism is to use shock wave energy to promote angiogenesis to achieve the functions of tissue repair and cell regeneration.
  arm group label: Group-1
  arm group label: Group-2
  intervention type: Drug
  intervention name: Tamsulosin
  description: Tamsulosin is a selective alpha-1 blocker, its main function is to relax the smooth muscles of the base of the prostate, urethra, and bladder, and improve lower urinary tract symptoms.
  arm group label: Group-3
  other name: Harnalidge 0.2mg
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jing-Dung Shen, MD
  role: Principal Investigator
  affiliation: Taichung Armed Forces General Hospital
  last name: Jing-Dung Shen, MD
  phone: +886958878129
  email: jdwhydo@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Taiwan
  citation: Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12.
  PMID: 32523286
  citation: Lee YC, Hsieh TJ, Tang FH, Jhan JH, Lin KL, Juan YS, Wang HS, Long CY. Therapeutic effect of Low intensity Extracorporeal Shock Wave Therapy (Li-ESWT) on diabetic bladder dysfunction in a rat model. Int J Med Sci. 2021 Jan 29;18(6):1423-1431. doi: 10.7150/ijms.55274. eCollection 2021.
  PMID: 33628099
  citation: Wang HS, Oh BS, Wang B, Ruan Y, Zhou J, Banie L, Lee YC, Tamaddon A, Zhou T, Wang G, Lin G, Lue TF. Low-intensity extracorporeal shockwave therapy ameliorates diabetic underactive bladder in streptozotocin-induced diabetic rats. BJU Int. 2018 Sep;122(3):490-500. doi: 10.1111/bju.14216. Epub 2018 Apr 20.
  PMID: 29603534
  citation: Dimitriadis F, Papaioannou M, Sokolakis I, Fragou A, Hatzichristou D, Apostolidis A. The Effect of Low-Intensity Extracorporeal Shockwave Treatment on the Urinary Bladder in an Experimental Diabetic Rat Model. Int Neurourol J. 2021 Mar;25(1):34-41. doi: 10.5213/inj.2040344.172. Epub 2021 Mar 6.
  PMID: 33676379
  citation: Chuang YC, Tyagi P, Luo HL, Lee WC, Wang HJ, Huang CC, Chancellor MB. Long-term functional change of cryoinjury-induced detrusor underactivity and effects of extracorporeal shock wave therapy in a rat model. Int Urol Nephrol. 2019 Apr;51(4):617-626. doi: 10.1007/s11255-019-02095-4. Epub 2019 Feb 22.
  PMID: 30796726
  citation: Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2.
  PMID: 28767169
  citation: Yoshida M, Sekido N, Matsukawa Y, Yono M, Yamaguchi O. Clinical diagnostic criteria for detrusor underactivity: A report from the Japanese Continence Society working group on underactive bladder. Low Urin Tract Symptoms. 2021 Jan;13(1):13-16. doi: 10.1111/luts.12356. Epub 2020 Oct 7.
  PMID: 33029933
  citation: Lin KL, Lu JH, Chueh KS, Juan TJ, Wu BN, Chuang SM, Lee YC, Shen MC, Long CY, Juan YS. Low-Intensity Extracorporeal Shock Wave Therapy Promotes Bladder Regeneration and Improves Overactive Bladder Induced by Ovarian Hormone Deficiency from Rat Animal Model to Human Clinical Trial. Int J Mol Sci. 2021 Aug 27;22(17):9296. doi: 10.3390/ijms22179296.
  PMID: 34502202
  responsible party type: Principal Investigator
  investigator affiliation: Taichung Armed Forces General Hospital
  investigator full name: Jing-Dung, SHEN
  investigator title: Director of Urology
  mesh term: Hypokinesia
  mesh term: Urinary Bladder, Underactive
  mesh term: Tamsulosin
  sharing ipd: No