<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/NCT03767595</url>
  </required_header>
  <id_info>
    <org_study_id>PAS001</org_study_id>
    <nct_id>NCT03767595</nct_id>
  </id_info>
  <brief_title>ProACT Post-Approval Study</brief_title>
  <official_title>Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uromedica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uromedica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study&#xD;
      designed to evaluate the long-term incidence of urethral stricture and device erosion after&#xD;
      ProACT implantation. In addition, the study will evaluate whether treatment with ProACT&#xD;
      affects clinical outcomes after subsequent SUI therapies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urethral Strictures</measure>
    <time_frame>5 years</time_frame>
    <description>Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device Erosions</measure>
    <time_frame>5 years</time_frame>
    <description>Cumulative incidence of ProACT device erosions over 5 years of follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incontinence Quality of Life Questionnaire (I-QoL)</measure>
    <time_frame>5 years</time_frame>
    <description>Results on Validated Incontinence Quality of Life Questionnaire</description>
  </primary_outcome>
  <other_outcome>
    <measure>Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy</measure>
    <time_frame>5 years</time_frame>
    <description>This data will be collected with a &quot;Post ProACT Explant Subsequent Therapy Questionnaire&quot;.&#xD;
This questionnaire will ask 3 questions regarding the ProACT therapy&#xD;
Did the ProACT therapy have a detrimental effect on the difficulty of the subsequent implant surgery?&#xD;
Did the ProACT therapy significantly increase the time required to implant the subsequent implant surgery?&#xD;
Did the ProACT therapy increase the surgical complication rate during the subsequent implant surgery?&#xD;
The scale for each question is 0-1. 0 Meaning no effect (a &quot;No&quot; response on the questionnaire) and 1 being some effect (&quot;Yes&quot; response on the questionnaire). No effect (0) on subsequent SUI therapies is the better outcome.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>ProACT Adjustable Continence Therapy for Men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients implanted with ProACT Adjustable Continence Therapy for Men</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProACT Adjustable Continence Therapy for Men</intervention_name>
    <description>The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.</description>
    <arm_group_label>ProACT Adjustable Continence Therapy for Men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is a male of at least 50 years of age.&#xD;
&#xD;
          2. Subject demonstrates stress urinary incontinence.&#xD;
&#xD;
          3. Subject has undergone a radical prostatectomy, transurethral resection of the&#xD;
             prostate, or other prostate surgery.&#xD;
&#xD;
          4. Subject is willing and able to undergo surgical implantation of ProACT devices.&#xD;
&#xD;
          5. Subject is willing and able to comply with study-required&#xD;
&#xD;
             follow-up activities, including annual telephonic follow -up interviews, for a period&#xD;
             of 5 years from their date of initial implantation. This includes compliance even&#xD;
             after possible explant of ProACT devices and/or possible implantation of subsequent&#xD;
             therapies.&#xD;
&#xD;
          6. Subject is willing and able to sign the approved informed consent.&#xD;
&#xD;
          7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad&#xD;
             weight increase demonstrated in two 24-hour pad weight tests).&#xD;
&#xD;
          8. Subject has a negative urine culture.&#xD;
&#xD;
          9. Subject has no known urogenital malignancy, other than previously treated prostate&#xD;
             cancer.&#xD;
&#xD;
         10. Subject meets ONE of the following criteria:&#xD;
&#xD;
               1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;&#xD;
&#xD;
               2. Baseline PSA &gt; 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater&#xD;
                  than or equal to 25% of total PSA;&#xD;
&#xD;
         11. Physician determines subject to be a suitable surgical candidate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has an existing urethral stricture, a history of any urethral strictures, or&#xD;
             has ever had a urethrotomy.&#xD;
&#xD;
          2. Subject has undergone prostate surgery or any anti-incontinence surgery within the&#xD;
             last 12 months.&#xD;
&#xD;
          3. Subject has an artificial urinary sphincter or any components of a previously&#xD;
             implanted artificial urinary sphincter in vivo.&#xD;
&#xD;
          4. Subject has undergone radiation therapy in the prostatic area within the last 12&#xD;
             months.&#xD;
&#xD;
          5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.&#xD;
&#xD;
          6. Subject has an atonic bladder.&#xD;
&#xD;
          7. Subject had, presently has, or is suspected of having bladder cancer.&#xD;
&#xD;
          8. Subject has untreated or unsuccessfully treated bladder stones.&#xD;
&#xD;
          9. Subject has detrusor sphincter dyssynergia.&#xD;
&#xD;
         10. Subject has known hemophilia or a bleeding disorder.&#xD;
&#xD;
         11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or&#xD;
             respiratory arrest).&#xD;
&#xD;
         12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as&#xD;
             indicated by an A1c test result of = 6.5%.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy C Cook, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Uromedica, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick Gora</last_name>
    <phone>7636949880</phone>
    <email>pgora@uromedica-inc.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Timothy C Cook, PhD</last_name>
    <phone>7636949880</phone>
    <email>regulatory@uromedica-inc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Pina</last_name>
      <email>andrea.pinalimones@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Brian Flynn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nate Coddington, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Marks, DHSc, CCRP</last_name>
      <phone>352-273-5618</phone>
      <email>John.Marks@urology.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Lawrence Yeung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sierra Williams</last_name>
      <phone>404-778-4729</phone>
      <email>sierra.williams@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Lindsey Hartsell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nailah Henry</last_name>
      <email>hnailah@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Bahaa Malaeb, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</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>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT03767595
org study id: PAS001
nct id: NCT03767595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study
      designed to evaluate the long-term incidence of urethral stricture and device erosion after
      ProACT implantation. In addition, the study will evaluate whether treatment with ProACT
      affects clinical outcomes after subsequent SUI therapies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Urethral Strictures
time frame: 5 years
description: Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
measure: Device Erosions
time frame: 5 years
description: Cumulative incidence of ProACT device erosions over 5 years of follow-up.
measure: Incontinence Quality of Life Questionnaire (I-QoL)
time frame: 5 years
description: Results on Validated Incontinence Quality of Life Questionnaire
measure: Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy
time frame: 5 years
description: This data will be collected with a "Post ProACT Explant Subsequent Therapy Questionnaire".
This questionnaire will ask 3 questions regarding the ProACT therapy
Did the ProACT therapy have a detrimental effect on the difficulty of the subsequent implant surgery?
Did the ProACT therapy significantly increase the time required to implant the subsequent implant surgery?
Did the ProACT therapy increase the surgical complication rate during the subsequent implant surgery?
The scale for each question is 0-1. 0 Meaning no effect (a "No" response on the questionnaire) and 1 being some effect ("Yes" response on the questionnaire). No effect (0) on subsequent SUI therapies is the better outcome.
arm group label: ProACT Adjustable Continence Therapy for Men
arm group type: Experimental
description: Patients implanted with ProACT Adjustable Continence Therapy for Men
intervention type: Device
intervention name: ProACT Adjustable Continence Therapy for Men
description: The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.
arm group label: ProACT Adjustable Continence Therapy for Men
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Timothy C Cook, PhD
role: Study Director
affiliation: Uromedica, Inc.
last name: Patrick Gora
phone: 7636949880
email: pgora@uromedica-inc.com
last name: Timothy C Cook, PhD
phone: 7636949880
email: regulatory@uromedica-inc.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Urinary Incontinence, Stress