<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/NCT04416802</url>
  </required_header>
  <id_info>
    <org_study_id>N201907013</org_study_id>
    <nct_id>NCT04416802</nct_id>
  </id_info>
  <brief_title>Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)</brief_title>
  <official_title>A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University 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>
      The purpose of this clinical study is mainly to use platelet-rich plasma combined with&#xD;
      low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction&#xD;
      and observe the improvement results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male&#xD;
      population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent.&#xD;
      At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee&#xD;
      show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction.&#xD;
      Erectile dysfunction is the most common sexual dysfunction in men and is believed to be&#xD;
      related to nerve or blood vessel damage, and often significantly affects the patients'&#xD;
      quality of life.&#xD;
&#xD;
      PRP is the abbreviation of &quot;platelet-rich plasma&quot;. It can release growth factors and&#xD;
      cytokines in the body to further promote tissue repair. The results of pre-clinical and&#xD;
      clinical trials show that PRP can promote the repair of cavernous tissue, protect erection&#xD;
      function of nerve, and stimulate the regeneration of nerve.&#xD;
&#xD;
      Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under&#xD;
      this treatment, it will help body producing angiogenesis-related proteins, stimulating the&#xD;
      formation of small blood vessels, generating new blood vessels at the site to be treated, and&#xD;
      increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a&#xD;
      significant effect on erectile dysfunction.&#xD;
&#xD;
      The purpose of this clinical study is mainly to use platelet-rich plasma combined with&#xD;
      low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction&#xD;
      and observe the improvement results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 28, 2020</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change in Erectile Function</measure>
    <time_frame>Baseline, the 4th week, 8th week, and 12th weeks</time_frame>
    <description>Using the International Index of Erectile Function (IIEF) questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change in Erectile Function</measure>
    <time_frame>Baseline, the 4th week, 8th week, and 12th weeks</time_frame>
    <description>Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidents of Side Effects</measure>
    <time_frame>the 4th week, 8th week, and 12th weeks</time_frame>
    <description>To observe whether there are side effects</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>PRP and Li-ESWT treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy</intervention_name>
    <description>The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria.&#xD;
To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment.&#xD;
Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment.&#xD;
Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS.&#xD;
Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment.&#xD;
Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS.&#xD;
Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.</description>
    <arm_group_label>PRP and Li-ESWT treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Impotence for more than three months&#xD;
&#xD;
          -  International index of erectile function, (IIEF) less than 21( including 21)&#xD;
&#xD;
          -  Erectile hardness score, (EHS) less than 3( including 3)&#xD;
&#xD;
          -  Age over 30 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypogonadism&#xD;
&#xD;
          -  Bleeding tendency&#xD;
&#xD;
          -  Could not cooperate with the treatment&#xD;
&#xD;
          -  AIDS, syphilis and condyloma victim&#xD;
&#xD;
          -  Received radical prostatectomy&#xD;
&#xD;
          -  Prostate cancer or pelvis malignant tumor victim&#xD;
&#xD;
          -  Gonad dysfunction&#xD;
&#xD;
          -  Penis deformities&#xD;
&#xD;
          -  Penile prosthesis implantation&#xD;
&#xD;
          -  Psychiatric disease victim&#xD;
&#xD;
          -  Neural disease ( multiple myeloma , brain atrophy, etc)&#xD;
&#xD;
          -  Pacemaker implantation&#xD;
&#xD;
          -  Not suitable join this trial judged by Investigator&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Che Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Che Liu, MD</last_name>
    <phone>886-2-2737-2181</phone>
    <phone_ext>1981</phone_ext>
    <email>d204097002@tmu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yi-Jen Su</last_name>
    <phone>886-2-2737-2181</phone>
    <phone_ext>5027</phone_ext>
    <email>175275@h.tmu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ming-Che Liu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Sanderson LM, Bryant A. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review. J Foot Ankle Res. 2015 Oct 20;8:57. doi: 10.1186/s13047-015-0114-5. eCollection 2015. Erratum In: J Foot Ankle Res. 2015;8:60.</citation>
    <PMID>26500703</PMID>
  </reference>
  <reference>
    <citation>Rosenthal AR, Harbury C, Egbert PR, Rubenstein E. Use of a platelet-fibrinogen-thrombin mixture as a corneal adhesive: experiments with sutureless lamellar keratoplasty in the rabbit. Invest Ophthalmol. 1975 Nov;14(11):872-5.</citation>
    <PMID>1102485</PMID>
  </reference>
  <reference>
    <citation>Wu YN, Wu CC, Sheu MT, Chen KC, Ho HO, Chiang HS. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med. 2016 Oct;10(10):E294-E304. doi: 10.1002/term.1806. Epub 2013 Aug 16.</citation>
    <PMID>23950105</PMID>
  </reference>
  <reference>
    <citation>Wu CC, Wu YN, Ho HO, Chen KC, Sheu MT, Chiang HS. The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. J Sex Med. 2012 Nov;9(11):2838-48. doi: 10.1111/j.1743-6109.2012.02881.x. Epub 2012 Aug 20.</citation>
    <PMID>22906160</PMID>
  </reference>
  <reference>
    <citation>Ruan Y, Zhou J, Kang N, Reed-Maldonado AB, Tamaddon A, Wang B, Wang HS, Wang G, Banie L, Lin G, Liu J, Lue TF. The effect of low-intensity extracorporeal shockwave therapy in an obesity-associated erectile dysfunction rat model. BJU Int. 2018 Jul;122(1):133-142. doi: 10.1111/bju.14202. Epub 2018 Apr 17.</citation>
    <PMID>29573106</PMID>
  </reference>
  <reference>
    <citation>Scott S, Roberts M, Chung E. Platelet-Rich Plasma and Treatment of Erectile Dysfunction: Critical Review of Literature and Global Trends in Platelet-Rich Plasma Clinics. Sex Med Rev. 2019 Apr;7(2):306-312. doi: 10.1016/j.sxmr.2018.12.006. Epub 2019 Mar 2.</citation>
    <PMID>30833169</PMID>
  </reference>
  <reference>
    <citation>Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.</citation>
    <PMID>31027441</PMID>
  </reference>
  <reference>
    <citation>Patel P, Huang C, Molina M, Ramasamy R. Clinical trial update on shockwave therapy and future of erectile function restoration. Int J Impot Res. 2019 May;31(3):206-208. doi: 10.1038/s41443-019-0115-1. Epub 2019 Jan 22.</citation>
    <PMID>30670840</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Ming-Che Liu, MD</investigator_full_name>
    <investigator_title>Director of Clinical Research Center</investigator_title>
  </responsible_party>
  <keyword>erectile dysfunction</keyword>
  <keyword>platelet-rich plasma</keyword>
  <keyword>low-intensity extracorporeal shockwave therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04416802
org study id: N201907013
nct id: NCT04416802
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical study is mainly to use platelet-rich plasma combined with
      low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction
      and observe the improvement results.
According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male
      population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent.
      At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee
      show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction.
      Erectile dysfunction is the most common sexual dysfunction in men and is believed to be
      related to nerve or blood vessel damage, and often significantly affects the patients'
      quality of life.

      PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and
      cytokines in the body to further promote tissue repair. The results of pre-clinical and
      clinical trials show that PRP can promote the repair of cavernous tissue, protect erection
      function of nerve, and stimulate the regeneration of nerve.

      Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under
      this treatment, it will help body producing angiogenesis-related proteins, stimulating the
      formation of small blood vessels, generating new blood vessels at the site to be treated, and
      increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a
      significant effect on erectile dysfunction.

      The purpose of this clinical study is mainly to use platelet-rich plasma combined with
      low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction
      and observe the improvement results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Change in Erectile Function
time frame: Baseline, the 4th week, 8th week, and 12th weeks
description: Using the International Index of Erectile Function (IIEF) questionnaire.
measure: The Change in Erectile Function
time frame: Baseline, the 4th week, 8th week, and 12th weeks
description: Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT
measure: Incidents of Side Effects
time frame: the 4th week, 8th week, and 12th weeks
description: To observe whether there are side effects
arm group label: PRP and Li-ESWT treatment
arm group type: Experimental
description: Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy.
intervention type: Combination Product
intervention name: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
description: The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria.
To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment.
Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment.
Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment.
Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
arm group label: PRP and Li-ESWT treatment
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ming-Che Liu, MD
role: Principal Investigator
affiliation: Taipei Medical University Hospital
last name: Ming-Che Liu, MD
phone: 886-2-2737-2181
phone ext: 1981
email: d204097002@tmu.edu.tw
last name: Yi-Jen Su
phone: 886-2-2737-2181
phone ext: 5027
email: 175275@h.tmu.edu.tw
facility: 
status: Recruiting
investigator: 
country: Taiwan
citation: Sanderson LM, Bryant A. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review. J Foot Ankle Res. 2015 Oct 20;8:57. doi: 10.1186/s13047-015-0114-5. eCollection 2015. Erratum In: J Foot Ankle Res. 2015;8:60.
PMID: 26500703
citation: Rosenthal AR, Harbury C, Egbert PR, Rubenstein E. Use of a platelet-fibrinogen-thrombin mixture as a corneal adhesive: experiments with sutureless lamellar keratoplasty in the rabbit. Invest Ophthalmol. 1975 Nov;14(11):872-5.
PMID: 1102485
citation: Wu YN, Wu CC, Sheu MT, Chen KC, Ho HO, Chiang HS. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med. 2016 Oct;10(10):E294-E304. doi: 10.1002/term.1806. Epub 2013 Aug 16.
PMID: 23950105
citation: Wu CC, Wu YN, Ho HO, Chen KC, Sheu MT, Chiang HS. The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. J Sex Med. 2012 Nov;9(11):2838-48. doi: 10.1111/j.1743-6109.2012.02881.x. Epub 2012 Aug 20.
PMID: 22906160
citation: Ruan Y, Zhou J, Kang N, Reed-Maldonado AB, Tamaddon A, Wang B, Wang HS, Wang G, Banie L, Lin G, Liu J, Lue TF. The effect of low-intensity extracorporeal shockwave therapy in an obesity-associated erectile dysfunction rat model. BJU Int. 2018 Jul;122(1):133-142. doi: 10.1111/bju.14202. Epub 2018 Apr 17.
PMID: 29573106
citation: Scott S, Roberts M, Chung E. Platelet-Rich Plasma and Treatment of Erectile Dysfunction: Critical Review of Literature and Global Trends in Platelet-Rich Plasma Clinics. Sex Med Rev. 2019 Apr;7(2):306-312. doi: 10.1016/j.sxmr.2018.12.006. Epub 2019 Mar 2.
PMID: 30833169
citation: Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
PMID: 31027441
citation: Patel P, Huang C, Molina M, Ramasamy R. Clinical trial update on shockwave therapy and future of erectile function restoration. Int J Impot Res. 2019 May;31(3):206-208. doi: 10.1038/s41443-019-0115-1. Epub 2019 Jan 22.
PMID: 30670840
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University Hospital
investigator full name: Ming-Che Liu, MD
investigator title: Director of Clinical Research Center
mesh term: Erectile Dysfunction
sharing ipd: No