<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/NCT04434352</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-HSR# 190082</org_study_id>
    <nct_id>NCT04434352</nct_id>
  </id_info>
  <brief_title>Low Intensity Shockwave Therapy for Erectile Dysfunction</brief_title>
  <official_title>Low Intensity Shockwave Therapy for Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low-intensity shockwave therapy (LiSWT) has been deemed &quot;a safe and well-tolerated procedure&#xD;
      but its efficacy for the treatment of ED is doubtful and deserves more investigation&quot; by the&#xD;
      European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of&#xD;
      North America and American Urological Association have put forth guideline statements&#xD;
      recommending additional investigation of this treatment modality.2&#xD;
&#xD;
      The current clinical armamentarium only treats the symptoms of erectile dysfunction without&#xD;
      improving upon the underlying pathophysiology. LiSWT has been used effectively in&#xD;
      musculoskeletal disorders and cardiovascular applications. Animal studies have shown&#xD;
      improvements in angiogenesis and stem cell recruitment in other systems (cardiac and&#xD;
      musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction&#xD;
      since 2010 and is widely used in Europe and throughout the world. It is gaining widespread&#xD;
      acceptance in the United States with a relative paucity of data in regards to its&#xD;
      effectiveness.&#xD;
&#xD;
      While the majority of studies and meta-analyses show improvements in standardized erectile&#xD;
      dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of&#xD;
      Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In&#xD;
      addition, many studies have failed to assess a population of men who have highly prevalent&#xD;
      erectile dysfunction, those men undergoing prostate cancer treatment.&#xD;
&#xD;
      This is a prospective, randomized, single blind, sham-controlled clinical study aimed to&#xD;
      evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED&#xD;
      patients in three distinct patient populations. LiSWT has shown the potential to improve&#xD;
      baseline erectile function but requires further study, which is the aim of this&#xD;
      investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is estimated that about 1 in 10 adult males suffer from erectile dysfunction (ED) on a&#xD;
      long-term basis. Oral therapies, including PDE5I, may be considered first-line therapies for&#xD;
      the majority of patients with ED because of potential benefits and lack of invasiveness. This&#xD;
      is a prospective, randomized, single-blind, sham-controlled clinical study aimed to evaluate&#xD;
      the safety and efficacy of low-intensity shockwave therapy on symptomatic ED patients in&#xD;
      three distinct patient populations.&#xD;
&#xD;
      The first arm of the study will be those men with erectile dysfunction as defined by IIEF&#xD;
      score (International Index of Erectile Function-5). These men will either have PDE5i&#xD;
      refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment&#xD;
      (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow&#xD;
      up will occur at 1 month, 3 months, and 6 months following the end of treatment.&#xD;
      Effectiveness will be measured by change in IIEF/SHIM (IIEF/SHIM-Sexual Health Inventory in&#xD;
      Men, International Index of Erectile Function-5) score and EHS (Erection Hardness Score)&#xD;
      score.&#xD;
&#xD;
      The Sexual Health Inventory in Men (also referred to as International Index of Erectile&#xD;
      Function-5) is scored as follows:&#xD;
&#xD;
      22-25 No erectile dysfunction 17-21 Mild erectile dysfunction 12-16 Mild-to-moderate erectile&#xD;
      dysfunction 8-11 Moderate erectile dysfunction 5-7 Severe erectile dysfunction&#xD;
&#xD;
      The patient responds to the following questions:&#xD;
&#xD;
      Instructions Each question has 5 possible responses. Circle the number that best describes&#xD;
      your own situation.&#xD;
&#xD;
      Select only 1 answer for each question.&#xD;
&#xD;
      Over the past 6 months:&#xD;
&#xD;
        1. How do you rate your confidence that you could keep an erection? Very low (1), Low (2),&#xD;
           Moderate (3), High (4), Very high (5)&#xD;
&#xD;
        2. When you had erections with sexual stimulation, how often were your erections hard&#xD;
           enough for penetration (entering your partner)?&#xD;
&#xD;
           Almost never or never (1), A few times (much less than half the time) (2), Sometimes&#xD;
           (About half the time) (3), Most times (much more than half the time) (4), Almost always&#xD;
           or always (5)&#xD;
&#xD;
        3. During sexual intercourse, how often were you able to maintain your erection after you&#xD;
           had penetrated (entered) your partner?&#xD;
&#xD;
           Almost never or never (1), A few times (much less than half the time) (2), Sometimes&#xD;
           (About half the time) (3), Most times (much more than half the time) (4), Almost always&#xD;
           or always (5)&#xD;
&#xD;
        4. During sexual intercourse, how difficult was it to maintain your erection to completion&#xD;
           of intercourse?&#xD;
&#xD;
           Extremely difficult (1), Very difficult (2), Difficult (3), Slightly difficult (4), Not&#xD;
           difficult (5)&#xD;
&#xD;
        5. When you attempted sexual intercourse, how often was it satisfactory for you? Almost&#xD;
           never or never (1), A few times (much less than half the time) (2), Sometimes (About&#xD;
           half the time) (3), Most times (much more than half the time) (4), Almost always or&#xD;
           always (5)&#xD;
&#xD;
      An increase or decrease from baseline indicates improving or worsening erectile function. The&#xD;
      Erection Hardness score is another tool to evaluate erectile function and firmness. It is&#xD;
      scored as follows:&#xD;
&#xD;
      0-Penis does not enlarge&#xD;
&#xD;
        1. Penis is larger, but not hard&#xD;
&#xD;
        2. Penis is hard, but not hard enough for penetration&#xD;
&#xD;
        3. Penis is hard enough for penetration, but not completely hard&#xD;
&#xD;
        4. Penis is completely hard and fully rigid&#xD;
&#xD;
      These patients will be randomized in a 1:1 ratio into either the Sham or active treatment&#xD;
      groups in which a device called Duolith by Storz will be used to deliver shockwaves to the&#xD;
      penile tissue. The Duolith device is FDA-approved for treatment of musculoskeletal disorders&#xD;
      including plantar fasciitis but has more recently been investigated in erectile dysfunction&#xD;
      in both the United States and abroad.&#xD;
&#xD;
      The Duolith device is used to deliver low intensity shockwaves to the penile tissue. LiSWT&#xD;
      (Linear Shockwave Therapy) utilizes energy in the ultrasonic range. The focused energy, when&#xD;
      applied to tissue, has been postulated to improve stem cell recruitment and promote&#xD;
      angiogenesis. This has been demonstrated in animal modes.&#xD;
&#xD;
      The second population of patients will be those who are planning to undergo treatment for&#xD;
      prostate cancer. In a similar manner, men will be randomized to either the Sham or active&#xD;
      treatment groups. Men will be treated prior to undergoing definitive treatment for prostate&#xD;
      cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to&#xD;
      prostate cancer treatment.&#xD;
&#xD;
      The third population of patients will be those who have undergone treatment for prostate&#xD;
      cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone&#xD;
      prostatectomy or radiation therapy. Again, there will be a sham and treatment group.&#xD;
&#xD;
      In addition to assessing the efficacy of LiSWT in these populations of men, the study aims&#xD;
      also to substantiate the safety profile of the Duolith device. Safety is to be assessed by&#xD;
      the frequency of side effects during treatment, as well as the occurrence of anticipated and&#xD;
      unanticipated adverse events during and from treatment up to follow-ups. The average and&#xD;
      standard deviation of all relevant variables, including demographic and baseline&#xD;
      characteristics, primary and secondary outcomes will be calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">March 7, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 7, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients will be randomized to either the treatment group or sham group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment</measure>
    <time_frame>1 month</time_frame>
    <description>The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function.&#xD;
Over the past 6 months:&#xD;
How do you rate your confidence that you could keep an erection?&#xD;
When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)?&#xD;
During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?&#xD;
During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?&#xD;
When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Changes in SHIM score (Sexual Health Inventory in Men) score at 3 and 6 months post-treatment.&#xD;
• The IIEF classifies men into groups of no erectile dysfunction, mild, mild to moderate, moderate and severe erectile dysfunction. Changes in the classifications will be compared between arms at 1, 3, and 6 months post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event Rates</measure>
    <time_frame>1, 3 and 6 months</time_frame>
    <description>Adverse Events including bruising and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Erection Hardness Score at 1, 3, and 6 months</measure>
    <time_frame>1, 3, and 6 months</time_frame>
    <description>Change in Erection Hardness Score&#xD;
The Erection Hardness score is another tool to evaluate erectile function and firmness. It is scored as follows:&#xD;
0-Penis does not enlarge&#xD;
Penis is larger, but not hard&#xD;
Penis is hard, but not hard enough for penetration&#xD;
Penis is hard enough for penetration, but not completely hard&#xD;
Penis is completely hard and fully rigid&#xD;
A higher score indicates a higher degree of erectile rigidity.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">338</enrollment>
  <condition>Erectile Dysfunction</condition>
  <condition>Erectile Dysfunction Following Radical Prostatectomy</condition>
  <condition>Erectile Dysfunction Following Radiation Therapy</condition>
  <condition>Erectile Dysfunction Due to General Medical Condition</condition>
  <condition>Erectile Dysfunction Due to Arterial Insufficiency</condition>
  <arm_group>
    <arm_group_label>Baseline Erectile Dysfunction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erectile Dysfunction-Penile Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erectile Dysfunction Post-Prostate Cancer Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Storz Duolith Low-Intensity Shockwave Therapy</intervention_name>
    <description>A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.&#xD;
B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.</description>
    <arm_group_label>Baseline Erectile Dysfunction</arm_group_label>
    <arm_group_label>Erectile Dysfunction Post-Prostate Cancer Treatment</arm_group_label>
    <arm_group_label>Erectile Dysfunction-Penile Rehabilitation</arm_group_label>
    <other_name>Sham</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must be willing and able to provide informed consent.&#xD;
&#xD;
          -  The patient is a male between &gt;30 and &lt;80 years of age.&#xD;
&#xD;
          -  PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication&#xD;
             for 2 weeks before baseline IIEF.&#xD;
&#xD;
          -  Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4&#xD;
             weeks before baseline IIEF.&#xD;
&#xD;
          -  Testosterone level &gt; 300 ng/dL. This includes patients on therapeutic testosterone&#xD;
             therapy.&#xD;
&#xD;
          -  If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.&#xD;
&#xD;
          -  Men who have undergone radical prostatectomy ≥ 12 months ago&#xD;
&#xD;
          -  Men who have undergone radiation therapy, either brachytherapy or external bean&#xD;
             therapy ≥ 12 months ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of extensive pelvic surgery ever.&#xD;
&#xD;
          -  Past radiation therapy of the pelvic region within 12 months prior to enrollment.&#xD;
&#xD;
          -  Recovering from any non-prostate related cancer within 12 months prior to enrollment.&#xD;
&#xD;
          -  Neurological disease which affects erectile function at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Anatomical malformation of the penis, including Peyronie's disease.&#xD;
&#xD;
          -  Testosterone level &lt;300 within 3 month prior to enrollment.&#xD;
&#xD;
          -  HgbA1C level &gt; 7.5% within 3 month prior to enrollment.&#xD;
&#xD;
          -  History of spinal cord injury.&#xD;
&#xD;
          -  Recovering from any non-prostate cancer malignancy within 12 months prior to&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Ryan Smith, MD</investigator_full_name>
    <investigator_title>Associate Professor of Urology</investigator_title>
  </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/NCT04434352
org study id: IRB-HSR# 190082
nct id: NCT04434352
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure
      but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the
      European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of
      North America and American Urological Association have put forth guideline statements
      recommending additional investigation of this treatment modality.2

      The current clinical armamentarium only treats the symptoms of erectile dysfunction without
      improving upon the underlying pathophysiology. LiSWT has been used effectively in
      musculoskeletal disorders and cardiovascular applications. Animal studies have shown
      improvements in angiogenesis and stem cell recruitment in other systems (cardiac and
      musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction
      since 2010 and is widely used in Europe and throughout the world. It is gaining widespread
      acceptance in the United States with a relative paucity of data in regards to its
      effectiveness.

      While the majority of studies and meta-analyses show improvements in standardized erectile
      dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of
      Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In
      addition, many studies have failed to assess a population of men who have highly prevalent
      erectile dysfunction, those men undergoing prostate cancer treatment.

      This is a prospective, randomized, single blind, sham-controlled clinical study aimed to
      evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED
      patients in three distinct patient populations. LiSWT has shown the potential to improve
      baseline erectile function but requires further study, which is the aim of this
      investigation.
It is estimated that about 1 in 10 adult males suffer from erectile dysfunction (ED) on a
      long-term basis. Oral therapies, including PDE5I, may be considered first-line therapies for
      the majority of patients with ED because of potential benefits and lack of invasiveness. This
      is a prospective, randomized, single-blind, sham-controlled clinical study aimed to evaluate
      the safety and efficacy of low-intensity shockwave therapy on symptomatic ED patients in
      three distinct patient populations.

      The first arm of the study will be those men with erectile dysfunction as defined by IIEF
      score (International Index of Erectile Function-5). These men will either have PDE5i
      refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment
      (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow
      up will occur at 1 month, 3 months, and 6 months following the end of treatment.
      Effectiveness will be measured by change in IIEF/SHIM (IIEF/SHIM-Sexual Health Inventory in
      Men, International Index of Erectile Function-5) score and EHS (Erection Hardness Score)
      score.

      The Sexual Health Inventory in Men (also referred to as International Index of Erectile
      Function-5) is scored as follows:

      22-25 No erectile dysfunction 17-21 Mild erectile dysfunction 12-16 Mild-to-moderate erectile
      dysfunction 8-11 Moderate erectile dysfunction 5-7 Severe erectile dysfunction

      The patient responds to the following questions:

      Instructions Each question has 5 possible responses. Circle the number that best describes
      your own situation.

      Select only 1 answer for each question.

      Over the past 6 months:

        1. How do you rate your confidence that you could keep an erection? Very low (1), Low (2),
           Moderate (3), High (4), Very high (5)

        2. When you had erections with sexual stimulation, how often were your erections hard
           enough for penetration (entering your partner)?

           Almost never or never (1), A few times (much less than half the time) (2), Sometimes
           (About half the time) (3), Most times (much more than half the time) (4), Almost always
           or always (5)

        3. During sexual intercourse, how often were you able to maintain your erection after you
           had penetrated (entered) your partner?

           Almost never or never (1), A few times (much less than half the time) (2), Sometimes
           (About half the time) (3), Most times (much more than half the time) (4), Almost always
           or always (5)

        4. During sexual intercourse, how difficult was it to maintain your erection to completion
           of intercourse?

           Extremely difficult (1), Very difficult (2), Difficult (3), Slightly difficult (4), Not
           difficult (5)

        5. When you attempted sexual intercourse, how often was it satisfactory for you? Almost
           never or never (1), A few times (much less than half the time) (2), Sometimes (About
           half the time) (3), Most times (much more than half the time) (4), Almost always or
           always (5)

      An increase or decrease from baseline indicates improving or worsening erectile function. The
      Erection Hardness score is another tool to evaluate erectile function and firmness. It is
      scored as follows:

      0-Penis does not enlarge

        1. Penis is larger, but not hard

        2. Penis is hard, but not hard enough for penetration

        3. Penis is hard enough for penetration, but not completely hard

        4. Penis is completely hard and fully rigid

      These patients will be randomized in a 1:1 ratio into either the Sham or active treatment
      groups in which a device called Duolith by Storz will be used to deliver shockwaves to the
      penile tissue. The Duolith device is FDA-approved for treatment of musculoskeletal disorders
      including plantar fasciitis but has more recently been investigated in erectile dysfunction
      in both the United States and abroad.

      The Duolith device is used to deliver low intensity shockwaves to the penile tissue. LiSWT
      (Linear Shockwave Therapy) utilizes energy in the ultrasonic range. The focused energy, when
      applied to tissue, has been postulated to improve stem cell recruitment and promote
      angiogenesis. This has been demonstrated in animal modes.

      The second population of patients will be those who are planning to undergo treatment for
      prostate cancer. In a similar manner, men will be randomized to either the Sham or active
      treatment groups. Men will be treated prior to undergoing definitive treatment for prostate
      cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to
      prostate cancer treatment.

      The third population of patients will be those who have undergone treatment for prostate
      cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone
      prostatectomy or radiation therapy. Again, there will be a sham and treatment group.

      In addition to assessing the efficacy of LiSWT in these populations of men, the study aims
      also to substantiate the safety profile of the Duolith device. Safety is to be assessed by
      the frequency of side effects during treatment, as well as the occurrence of anticipated and
      unanticipated adverse events during and from treatment up to follow-ups. The average and
      standard deviation of all relevant variables, including demographic and baseline
      characteristics, primary and secondary outcomes will be calculated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients will be randomized to either the treatment group or sham group.
measure: Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment
time frame: 1 month
description: The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function.
Over the past 6 months:
How do you rate your confidence that you could keep an erection?
When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)?
During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?
During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity.
measure: Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment
time frame: 3 and 6 months
description: Changes in SHIM score (Sexual Health Inventory in Men) score at 3 and 6 months post-treatment.
• The IIEF classifies men into groups of no erectile dysfunction, mild, mild to moderate, moderate and severe erectile dysfunction. Changes in the classifications will be compared between arms at 1, 3, and 6 months post-treatment.
measure: Adverse Event Rates
time frame: 1, 3 and 6 months
description: Adverse Events including bruising and pain.
measure: Change in Erection Hardness Score at 1, 3, and 6 months
time frame: 1, 3, and 6 months
description: Change in Erection Hardness Score
The Erection Hardness score is another tool to evaluate erectile function and firmness. It is scored as follows:
0-Penis does not enlarge
Penis is larger, but not hard
Penis is hard, but not hard enough for penetration
Penis is hard enough for penetration, but not completely hard
Penis is completely hard and fully rigid
A higher score indicates a higher degree of erectile rigidity.
arm group label: Baseline Erectile Dysfunction
arm group type: Active Comparator
description: The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.
arm group label: Erectile Dysfunction-Penile Rehabilitation
arm group type: Active Comparator
description: The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.
arm group label: Erectile Dysfunction Post-Prostate Cancer Treatment
arm group type: Active Comparator
description: The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.
intervention type: Device
intervention name: Storz Duolith Low-Intensity Shockwave Therapy
description: A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.
B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.
arm group label: Baseline Erectile Dysfunction
arm group label: Erectile Dysfunction Post-Prostate Cancer Treatment
arm group label: Erectile Dysfunction-Penile Rehabilitation
other name: Sham
criteria: 
gender: Male
gender based: Yes
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Ryan Smith, MD
investigator title: Associate Professor of Urology
mesh term: Erectile Dysfunction
sharing ipd: No