<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/NCT03237143</url>
  </required_header>
  <id_info>
    <org_study_id>BMGC-1</org_study_id>
    <nct_id>NCT03237143</nct_id>
  </id_info>
  <brief_title>Low-intensity Extracorporeal Shock Wave for Erectile Disfunction</brief_title>
  <official_title>Quality of Erections After Completing a Low-intensity Extracorporeal Shock Wave Treatment Cycle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Group</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>
      Introduction: Erectile dysfunction occurs in a high percentage of patients today, showing not&#xD;
      only an association with various pathologies but also frequent refractoriness to conventional&#xD;
      pharmacological treatment options such as monotherapy. The objective of this study is to&#xD;
      evaluate the response to low-intensity extracorporeal shock wave therapy in a group of&#xD;
      patients with organic vascular erectile dysfunction with a history of more than three months.&#xD;
&#xD;
      Materials and Methods: Observational retrospective study. The researchers reviewed clinical&#xD;
      records of patients with a clinical diagnosis of organic vascular erectile dysfunction (ED)&#xD;
      of more than 3 months duration, who received 5 outpatient shock wave therapy sessions, in the&#xD;
      male sexual health clinics of the Boston Medical Group from Spain and Mexico. The patients&#xD;
      were evaluated with the erection hardness score (EHS) before the first session, at the end of&#xD;
      the last session and one month after the last session.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical records of patients over 18 years of age with a clinical diagnosis of organic&#xD;
      vascular ED, of more than three months and with an erection hardness score (EHS)(17) of three&#xD;
      or less, treated between April 2014 and February 2015 in the Boston Medical Group male sexual&#xD;
      health clinics of twelve cities in Spain (Madrid, Barcelona, Valencia, Seville, Coruña,&#xD;
      Bilbao, Malaga, Zaragoza, Murcia, Alicante, Cordoba and Jerez) and four in Mexico (Altavista,&#xD;
      Reforma, Monterrey and Naucalpan), were reviewed. The researchers excluded patients with ED&#xD;
      caused by side effects from drugs or spinal cord injury; situational ED (obvious&#xD;
      psychological origin); lesions, loss of skin or penile implant; and patients who did not&#xD;
      adequately complete the LI-ESWT (Low-intensity extracorporeal shock wave therapy).&#xD;
&#xD;
      After the initial assessment and diagnosis consultation, each patient received a treatment of&#xD;
      5 sessions (1 session per week) of 20 minutes of LI-ESWT, carried out with the DUOLITH SD1&#xD;
      (Storz Tägerwilen, Switzerland). They received 3,000 impulses per session at 0.1 mJ/mm2,&#xD;
      divided over six sites, four on the penis and two on the crura. All sessions were outpatient&#xD;
      visits and no anaesthetic was used. The EHS for all patients was measured at three stages:&#xD;
      before the first session, at the end of the last session (5 weeks after the first session)&#xD;
      and one month after the last session. When patients were receiving concomitant drug treatment&#xD;
      for their dysfunction, they were asked to indicate their perception free of the effect&#xD;
      thereof. All the clinical information was recorded by qualified physicians on a standardised&#xD;
      form using centralised software on a secure server.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The research question was resolved in a metanalysis&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">January 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Erection hardness score</measure>
    <time_frame>one month after the last session</time_frame>
    <description>Erection hardness score (EHS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erection hardness score</measure>
    <time_frame>At the end after the last session</time_frame>
    <description>Erection hardness score (EHS)</description>
  </secondary_outcome>
  <enrollment type="Actual">710</enrollment>
  <condition>Erectile Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated between April 2014 and February 2015 in the Boston Medical Group male&#xD;
        sexual health clinics of twelve cities in Spain (Madrid, Barcelona, Valencia, Seville,&#xD;
        Coruña, Bilbao, Malaga, Zaragoza, Murcia, Alicante, Cordoba and Jerez) and four in Mexico&#xD;
        (Altavista, Reforma, Monterrey and Naucalpan)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years of age&#xD;
&#xD;
          -  clinical diagnosis of organic vascular ED of more than three months and with an&#xD;
             erection hardness score (EHS) of three or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with ED caused by side effects from drugs or spinal cord injury&#xD;
&#xD;
          -  situational ED (obvious psychological origin)&#xD;
&#xD;
          -  lesions, loss of skin or penile implant&#xD;
&#xD;
          -  patients who did not adequately complete the LI-ESWT&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03237143
org study id: BMGC-1
nct id: NCT03237143
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Erectile dysfunction occurs in a high percentage of patients today, showing not
      only an association with various pathologies but also frequent refractoriness to conventional
      pharmacological treatment options such as monotherapy. The objective of this study is to
      evaluate the response to low-intensity extracorporeal shock wave therapy in a group of
      patients with organic vascular erectile dysfunction with a history of more than three months.

      Materials and Methods: Observational retrospective study. The researchers reviewed clinical
      records of patients with a clinical diagnosis of organic vascular erectile dysfunction (ED)
      of more than 3 months duration, who received 5 outpatient shock wave therapy sessions, in the
      male sexual health clinics of the Boston Medical Group from Spain and Mexico. The patients
      were evaluated with the erection hardness score (EHS) before the first session, at the end of
      the last session and one month after the last session.
Clinical records of patients over 18 years of age with a clinical diagnosis of organic
      vascular ED, of more than three months and with an erection hardness score (EHS)(17) of three
      or less, treated between April 2014 and February 2015 in the Boston Medical Group male sexual
      health clinics of twelve cities in Spain (Madrid, Barcelona, Valencia, Seville, Coruña,
      Bilbao, Malaga, Zaragoza, Murcia, Alicante, Cordoba and Jerez) and four in Mexico (Altavista,
      Reforma, Monterrey and Naucalpan), were reviewed. The researchers excluded patients with ED
      caused by side effects from drugs or spinal cord injury; situational ED (obvious
      psychological origin); lesions, loss of skin or penile implant; and patients who did not
      adequately complete the LI-ESWT (Low-intensity extracorporeal shock wave therapy).

      After the initial assessment and diagnosis consultation, each patient received a treatment of
      5 sessions (1 session per week) of 20 minutes of LI-ESWT, carried out with the DUOLITH SD1
      (Storz Tägerwilen, Switzerland). They received 3,000 impulses per session at 0.1 mJ/mm2,
      divided over six sites, four on the penis and two on the crura. All sessions were outpatient
      visits and no anaesthetic was used. The EHS for all patients was measured at three stages:
      before the first session, at the end of the last session (5 weeks after the first session)
      and one month after the last session. When patients were receiving concomitant drug treatment
      for their dysfunction, they were asked to indicate their perception free of the effect
      thereof. All the clinical information was recorded by qualified physicians on a standardised
      form using centralised software on a secure server.
observational model: Cohort
time perspective: Retrospective
measure: Erection hardness score
time frame: one month after the last session
description: Erection hardness score (EHS)
measure: Erection hardness score
time frame: At the end after the last session
description: Erection hardness score (EHS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No