<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/NCT03308409</url>
  </required_header>
  <id_info>
    <org_study_id>BMGC-3</org_study_id>
    <nct_id>NCT03308409</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction</brief_title>
  <official_title>Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction</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>
      The patients with primary erectile dysfunction (IIEF-EF &lt;26 points), will be randomly&#xD;
      assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week;&#xD;
      Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions&#xD;
      (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores&#xD;
      will be compared as well as the possible adverse events from the therapy upon beginning and&#xD;
      completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality&#xD;
      of life will also be evaluated using the SEAR scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IIEF-EF score 6 months after completing the treatment</measure>
    <time_frame>6 month follow-ups</time_frame>
    <description>This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment. The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15). The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erection Hardness Score</measure>
    <time_frame>3-month and 6-month follow-ups</time_frame>
    <description>The EHS has a single Likert scale: 0 = Penis does not increase in size; 1= the penis increases in size but is not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>6-month follow-ups</time_frame>
    <description>For patients with moderate ED, a 5-point increase in the IIEF-EF score is considered improvement. For patients with mild ED a 2-point increase on this scale is considered improvement. And for those with severe ED a 7-point change is considered improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of satisfactory relations</measure>
    <time_frame>3-month and 6-month follow-ups</time_frame>
    <description>According to the patient's journal records. For the purpose of this study, satisfactory relations are defined as the increase in rigidity and duration of the erection as evaluated by the patient and his partner. For patients who were not able to penetrate before treatment, satisfactory relations will include not only an increase in rigidity and duration of the erection but also the ability to penetrate.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">279</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Protocol 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protocol 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protocol 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-intensity extracorporeal shock wave therapy (Li-ESWT)</intervention_name>
    <description>Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds. They generate a pressure pulse and transport energy as they propagate through a medium. Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity. Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue. This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.</description>
    <arm_group_label>Protocol 1</arm_group_label>
    <arm_group_label>Protocol 2</arm_group_label>
    <arm_group_label>Protocol 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men over 18 years of age&#xD;
&#xD;
          -  Presence of ED for more than 3 months in over 50% of sexual intercourses.&#xD;
&#xD;
          -  Baseline ED domain score under 26 on the IIEF-15 EF domain.&#xD;
&#xD;
          -  Patient agrees to participate in the trial by providing signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  EHS score of 4.&#xD;
&#xD;
          -  Patients with an INR over 3.&#xD;
&#xD;
          -  Patients with sickle-cell anemia.&#xD;
&#xD;
          -  Patients with clinical suspicion of hypogonadism (AMS over 36).&#xD;
&#xD;
          -  Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's&#xD;
             disease, hyperprolactinemia, androgen deficiency.&#xD;
&#xD;
          -  Active vesicular, prostrate or colon cancer.&#xD;
&#xD;
          -  Radical prostatectomy or other radical pelvic surgery.&#xD;
&#xD;
          -  History of pelvic radiation therapy.&#xD;
&#xD;
          -  Patients with ED of psychological origin.&#xD;
&#xD;
          -  Spinal cord injury or other neurological diseases associated with ED.&#xD;
&#xD;
          -  Anatomical penile dysfunction, penile implant.&#xD;
&#xD;
          -  Patients with active infections or lesions on the penis or pubic area.&#xD;
&#xD;
          -  Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for&#xD;
             BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).&#xD;
&#xD;
          -  Abuse of psychoactive substances.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>José Saffon, Doctor</last_name>
    <phone>3208899777</phone>
    <phone_ext>104</phone_ext>
    <email>jpsaffon@bostonmedical.com.co</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Medical Group Colombia</name>
      <address>
        <city>Bogotá</city>
        <state>Cundinamarca</state>
        <zip>11022</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolina Sandoval</last_name>
      <phone>57 3208899777</phone>
      <email>csandoval@bostonmedical.com.co</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Boston Medical Group</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jorge Barba</last_name>
      <email>jbarba@bostonmedical.com.mx</email>
    </contact>
  </location>
  <location_countries>
    <country>Colombia</country>
    <country>Mexico</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 9, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 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/NCT03308409
org study id: BMGC-3
nct id: NCT03308409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly
      assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week;
      Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions
      (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores
      will be compared as well as the possible adverse events from the therapy upon beginning and
      completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality
      of life will also be evaluated using the SEAR scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: IIEF-EF score 6 months after completing the treatment
time frame: 6 month follow-ups
description: This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment. The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15). The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.
measure: Erection Hardness Score
time frame: 3-month and 6-month follow-ups
description: The EHS has a single Likert scale: 0 = Penis does not increase in size; 1= the penis increases in size but is not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid
measure: Clinical improvement
time frame: 6-month follow-ups
description: For patients with moderate ED, a 5-point increase in the IIEF-EF score is considered improvement. For patients with mild ED a 2-point increase on this scale is considered improvement. And for those with severe ED a 7-point change is considered improvement.
measure: Number of satisfactory relations
time frame: 3-month and 6-month follow-ups
description: According to the patient's journal records. For the purpose of this study, satisfactory relations are defined as the increase in rigidity and duration of the erection as evaluated by the patient and his partner. For patients who were not able to penetrate before treatment, satisfactory relations will include not only an increase in rigidity and duration of the erection but also the ability to penetrate.
arm group label: Protocol 1
arm group type: Active Comparator
description: Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
arm group label: Protocol 2
arm group type: Experimental
description: Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
arm group label: Protocol 3
arm group type: Experimental
description: Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base
intervention type: Other
intervention name: Low-intensity extracorporeal shock wave therapy (Li-ESWT)
description: Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds. They generate a pressure pulse and transport energy as they propagate through a medium. Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity. Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue. This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
arm group label: Protocol 1
arm group label: Protocol 2
arm group label: Protocol 3
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José Saffon, Doctor
phone: 3208899777
phone ext: 104
email: jpsaffon@bostonmedical.com.co
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Colombia
country: Mexico
country: Brazil
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No