<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/NCT01718704</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00069795</org_study_id>
    <nct_id>NCT01718704</nct_id>
  </id_info>
  <brief_title>Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy</brief_title>
  <official_title>Study of Non-Invasive Viberect® Penile Vibratory Stimulation Regimen to Enhance Recovery of Erectile Function/Rigidity and Urinary Control/Continence After Nerve Sparing Radical Prostatectomy (RP) for Clinically Localized Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether using penile vibratory stimulation with the&#xD;
      Viberect handheld device can help the recovery of erections and urinary control after radical&#xD;
      prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer screening programs have led to thousands of sexually healthy and continent&#xD;
      men being diagnosed with prostate cancer every year. Recent literature suggests that up to&#xD;
      80% of these cancers are confined to the prostate gland. Currently, radical prostatectomy&#xD;
      (RP) remains the best option for management of clinically localized prostate cancer in men&#xD;
      with life expectancy greater than 10 years. Despite providing optimal cancer control, surgery&#xD;
      can lead to quality of life (QOL) problems such as urinary incontinence and erectile&#xD;
      dysfunction (ED). Refinement of surgical technique have improved sexual and continence&#xD;
      outcomes; however erectile function lags behind other QOL measures by 1-2 years, and quality&#xD;
      of returning erections is often inferior. This can have profound biological, marital, and&#xD;
      psychological consequences in potent men undergoing RP.&#xD;
&#xD;
      ED is the inability to develop and maintain an erection for satisfactory sexual intercourse&#xD;
      or activity. ED after nerve-sparing RP is related to a certain degree with functional&#xD;
      impairment of cavernous nerves (CN) that travel along the prostate to the penis. This&#xD;
      neuropraxia can last as long as 2 years. Pro-erectile nerve stimulus is vital for&#xD;
      replenishment of corporal oxygen supply and other metabolic needs. Several histological&#xD;
      analyses have demonstrated decreased smooth muscle number, cell-cell contact, venous leakage,&#xD;
      collagen deposition, and additional harmful effects to corporal tissue after injury to CN.&#xD;
&#xD;
      Awaiting post-surgical neuropraxia recovery, urologists have proposed a proactive approach to&#xD;
      use of oral, intraurethral or injectable pharmacotherapy, neuromodulation, or vacuum-assisted&#xD;
      regimens in erectile rehabilitation programs. Several studies demonstrate variable functional&#xD;
      improvement in erectile function. Unfortunately, prohibitive costs of medications, poor&#xD;
      response, and pain from injectables or intraurethral application often lead to high dropout&#xD;
      rates.&#xD;
&#xD;
      In addition to ED, a significant proportion of men after surgery develop and suffer from&#xD;
      urinary incontinence (Stress, Urge, Mixed) requiring wearing pads with bothersome complaints&#xD;
      persisting for months, even years after RP.&#xD;
&#xD;
      The primary objective is to assess the role of penile vibratory stimulation by the Viberect&#xD;
      device in enhancing the recovery of erectile function/rigidity and urinary continence after&#xD;
      RP for clinically localized prostate cancer. The difference in penile length will be compared&#xD;
      in each arm.&#xD;
&#xD;
      The secondary objective is to obtain a formal risk analysis (RA). Other objectives are to&#xD;
      assess the ease of use and acceptability of vibratory stimulation at home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was stopped due to inability to accrue patients because of competing trials.&#xD;
  </why_stopped>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">March 27, 2019</completion_date>
  <primary_completion_date type="Actual">March 27, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in erectile function (EF)</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>Measurement of penile length from corona to dorsal glans penis in centimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>Measurement of penile length from corona to dorsal glans penis in centimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>Measurement of penile length from corona to dorsal glans penis in centimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>Measurement of penile length from corona to dorsal glans penis in centimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in EF</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>Measurement of penile length from corona to dorsal glans penis in centimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>Mass of incontinence guards used over a 24 hour period in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>Mass of incontinence guards used over a 24 hour period in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>Mass of incontinence guards used over a 24 hour period in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>Mass of incontinence guards used over a 24 hour period in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>Mass of incontinence guards used over a 24 hour period in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in urinary control</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>6 weeks after first device use to 3 months</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>6 weeks after first device use to 6 months</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>6 weeks after first device use to 9 months</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>6 weeks after first device use to 12 months</time_frame>
    <description>The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>baseline to 6 weeks after first device use</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>baseline to 3 months after first device use</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>baseline to 6 months after first device use</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>baseline to 9 months after first device use</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>change in assessment of ease and acceptability of use of the Viberect</measure>
    <time_frame>baseline to 12 months after first device use</time_frame>
    <description>The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Erectile Dysfunction Following Radical Prostatectomy</condition>
  <condition>Urinary Incontinence of Non-organic Origin</condition>
  <arm_group>
    <arm_group_label>Viberect device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men in this group will begin using the Viberect device 3 days after Foley catheter removal after surgery on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Viberect</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Men in this group will not be provided with the Viberect device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Viberect device</intervention_name>
    <description>Men who begin using the Viberect device 3 days after Foley catheter removal on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner.</description>
    <arm_group_label>Viberect device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7,&#xD;
             3+2=5, 2+3=5, cT1c, cT2a, cT2b, preoperative prostatic specific antigen (PSA) less&#xD;
             than 10)&#xD;
&#xD;
          -  between ages 40-70&#xD;
&#xD;
          -  preoperative IIEF (erectile function domain) score equal or greater than 20&#xD;
&#xD;
          -  IPSS less than 10 and no urinary incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men with neurological disease&#xD;
&#xD;
          -  IIEF score less than 20&#xD;
&#xD;
          -  high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA &gt; 10)&#xD;
&#xD;
          -  spinal cord injury&#xD;
&#xD;
          -  history of transurethral resection of prostate (TURP) or other prostate ablative&#xD;
             procedures&#xD;
&#xD;
          -  history of priapism, pelvic neuropathy, penile skin lesions/ulcers&#xD;
&#xD;
          -  inability to understand and demonstrate device use instructions.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur L Burnett, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick Urology Specialists</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>erectile dysfunction</keyword>
  <keyword>incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718704
org study id: NA_00069795
nct id: NCT01718704
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate whether using penile vibratory stimulation with the
      Viberect handheld device can help the recovery of erections and urinary control after radical
      prostatectomy.
Prostate cancer screening programs have led to thousands of sexually healthy and continent
      men being diagnosed with prostate cancer every year. Recent literature suggests that up to
      80% of these cancers are confined to the prostate gland. Currently, radical prostatectomy
      (RP) remains the best option for management of clinically localized prostate cancer in men
      with life expectancy greater than 10 years. Despite providing optimal cancer control, surgery
      can lead to quality of life (QOL) problems such as urinary incontinence and erectile
      dysfunction (ED). Refinement of surgical technique have improved sexual and continence
      outcomes; however erectile function lags behind other QOL measures by 1-2 years, and quality
      of returning erections is often inferior. This can have profound biological, marital, and
      psychological consequences in potent men undergoing RP.

      ED is the inability to develop and maintain an erection for satisfactory sexual intercourse
      or activity. ED after nerve-sparing RP is related to a certain degree with functional
      impairment of cavernous nerves (CN) that travel along the prostate to the penis. This
      neuropraxia can last as long as 2 years. Pro-erectile nerve stimulus is vital for
      replenishment of corporal oxygen supply and other metabolic needs. Several histological
      analyses have demonstrated decreased smooth muscle number, cell-cell contact, venous leakage,
      collagen deposition, and additional harmful effects to corporal tissue after injury to CN.

      Awaiting post-surgical neuropraxia recovery, urologists have proposed a proactive approach to
      use of oral, intraurethral or injectable pharmacotherapy, neuromodulation, or vacuum-assisted
      regimens in erectile rehabilitation programs. Several studies demonstrate variable functional
      improvement in erectile function. Unfortunately, prohibitive costs of medications, poor
      response, and pain from injectables or intraurethral application often lead to high dropout
      rates.

      In addition to ED, a significant proportion of men after surgery develop and suffer from
      urinary incontinence (Stress, Urge, Mixed) requiring wearing pads with bothersome complaints
      persisting for months, even years after RP.

      The primary objective is to assess the role of penile vibratory stimulation by the Viberect
      device in enhancing the recovery of erectile function/rigidity and urinary continence after
      RP for clinically localized prostate cancer. The difference in penile length will be compared
      in each arm.

      The secondary objective is to obtain a formal risk analysis (RA). Other objectives are to
      assess the ease of use and acceptability of vibratory stimulation at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in erectile function
time frame: baseline to 6 weeks after first device use
description: The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
measure: change in erectile function
time frame: baseline to 3 months after first device use
description: IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
measure: change in erectile function
time frame: baseline to 6 months after first device use
description: IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
measure: change in erectile function
time frame: baseline to 9 months after first device use
description: The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
measure: change in erectile function
time frame: baseline to 12 months after first device use
description: The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
measure: change in erectile function
time frame: baseline to 6 weeks after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
measure: change in erectile function
time frame: baseline to 3 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
measure: change in erectile function
time frame: baseline to 6 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
measure: change in erectile function
time frame: baseline to 9 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
measure: change in erectile function
time frame: baseline to 12 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
measure: change in erectile function
time frame: baseline to 6 weeks after first device use
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
measure: change in erectile function
time frame: baseline to 3 months after first device use
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
measure: change in erectile function
time frame: baseline to 6 months after first device use
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
measure: change in erectile function (EF)
time frame: baseline to 9 months after first device use
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
measure: change in EF
time frame: baseline to 12 months after first device use
description: The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
measure: change in EF
time frame: baseline to 6 weeks after first device use
description: Measurement of penile length from corona to dorsal glans penis in centimeters
measure: change in EF
time frame: baseline to 3 months after first device use
description: Measurement of penile length from corona to dorsal glans penis in centimeters
measure: change in EF
time frame: baseline to 6 months after first device use
description: Measurement of penile length from corona to dorsal glans penis in centimeters
measure: change in EF
time frame: baseline to 9 months after first device use
description: Measurement of penile length from corona to dorsal glans penis in centimeters
measure: change in EF
time frame: baseline to 12 months after first device use
description: Measurement of penile length from corona to dorsal glans penis in centimeters
measure: change in urinary control
time frame: baseline to 6 weeks after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
measure: change in urinary control
time frame: baseline to 3 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
measure: change in urinary control
time frame: baseline to 6 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
measure: change in urinary control
time frame: baseline to 9 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
measure: change in urinary control
time frame: baseline to 12 months after first device use
description: The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
measure: change in urinary control
time frame: baseline to 6 weeks after first device use
description: Mass of incontinence guards used over a 24 hour period in grams
measure: change in urinary control
time frame: baseline to 3 months after first device use
description: Mass of incontinence guards used over a 24 hour period in grams
measure: change in urinary control
time frame: baseline to 6 months after first device use
description: Mass of incontinence guards used over a 24 hour period in grams
measure: change in urinary control
time frame: baseline to 9 months after first device use
description: Mass of incontinence guards used over a 24 hour period in grams
measure: change in urinary control
time frame: baseline to 12 months after first device use
description: Mass of incontinence guards used over a 24 hour period in grams
measure: change in urinary control
time frame: baseline to 6 weeks after first device use
description: The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
measure: change in urinary control
time frame: baseline to 3 months after first device use
description: The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
measure: change in urinary control
time frame: baseline to 6 months after first device use
description: The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
measure: change in urinary control
time frame: baseline to 9 months after first device use
description: The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
measure: change in urinary control
time frame: baseline to 12 months after first device use
description: The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: 6 weeks after first device use to 3 months
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: 6 weeks after first device use to 6 months
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: 6 weeks after first device use to 9 months
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: 6 weeks after first device use to 12 months
description: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: baseline to 6 weeks after first device use
description: The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: baseline to 3 months after first device use
description: The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: baseline to 6 months after first device use
description: The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: baseline to 9 months after first device use
description: The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
measure: change in assessment of ease and acceptability of use of the Viberect
time frame: baseline to 12 months after first device use
description: The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction
arm group label: Viberect device
arm group type: Experimental
description: Men in this group will begin using the Viberect device 3 days after Foley catheter removal after surgery on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting.
arm group label: No Viberect
arm group type: No Intervention
description: Men in this group will not be provided with the Viberect device
intervention type: Device
intervention name: Viberect device
description: Men who begin using the Viberect device 3 days after Foley catheter removal on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner.
arm group label: Viberect device
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Arthur L Burnett, MD, MBA
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Erectile Dysfunction