<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/NCT02983461</url>
  </required_header>
  <id_info>
    <org_study_id>15-0121</org_study_id>
    <nct_id>NCT02983461</nct_id>
  </id_info>
  <brief_title>Use of Sildenafil for Treatment of Urinary Incontinence</brief_title>
  <official_title>Use of Sildenafil for Treatment of Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators goal is to develop medical treatments for stress/mixed urinary&#xD;
      incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and&#xD;
      strength and to decrease muscle fatigue. The investigators believe that it will improve&#xD;
      muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related&#xD;
      to pelvic floor dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To determine the effect of sildenafil on urinary incontinence.&#xD;
&#xD;
        1. Episodes of urinary incontinence will be recorded using a 3 day bladder diary.&#xD;
&#xD;
        2. Quantitative assessment of urinary incontinence will be performed at baseline and after&#xD;
           treatment using a Pad Test.&#xD;
&#xD;
        3. Muscle strength will be assessed through use of a perineometer.&#xD;
&#xD;
        4. To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with&#xD;
           noninvasive imaging before and after randomization to sildenafil.&#xD;
&#xD;
        5. Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>Phase 1</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary Incontinence as measured by Pad Test</measure>
    <time_frame>10 weeks</time_frame>
    <description>Pad tests quantitatively measures urine leakage</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Double Blind Placebo 3 times a day for 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sildenafil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <description>Sildenafil, 20mg x 3 times a day for 10 weeks</description>
    <arm_group_label>Sildenafil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo oral tablet, 3 times a day for 10 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal females, 50-80 years of age, at the time of consent&#xD;
&#xD;
          -  Have stress or mixed urinary incontinence, with at least 3 episodes/week&#xD;
&#xD;
          -  Willing and able to comply with study procedures&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular&#xD;
             disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid&#xD;
             replacement is being administered. Thyroid testing will be performed at screening and&#xD;
             as needed during study visits. )&#xD;
&#xD;
          -  Systolic blood pressure &lt;100 or &gt;150, diastolic blood pressure &lt;60 or &gt;90 after&#xD;
             repeated evaluation with proper cuff. This range is smaller than the acceptable range&#xD;
             stated in the prescribing information for sildenafil (&gt;90/50 and &lt;170/110)&#xD;
&#xD;
          -  Diabetes mellitus or other untreated endocrine disease&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Currently using and planning to continue use of urinary incontinence medications&#xD;
             during study period&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  HIV, Hepatitis B, or Hepatitis C&#xD;
&#xD;
          -  Use of systemic nitrates, anabolic steroids or corticosteroids in the past 6 months&#xD;
&#xD;
          -  Use of alpha blockers&#xD;
&#xD;
          -  Any medical condition that, in the opinion of the investigator, would place the&#xD;
             subject at increased risk for participation.&#xD;
&#xD;
          -  Known allergic reaction to any agent under investigation or required by the protocol.&#xD;
&#xD;
          -  History of prior non-compliance or the presence or history of psychiatric condition&#xD;
             (including drug or alcohol addiction) that would, in the opinion of the investigator,&#xD;
             make it difficult for the subject to comply with the study procedures or follow the&#xD;
             investigators instructions.&#xD;
&#xD;
          -  Females who are pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen L Vincent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>June 22, 2023</last_update_submitted>
  <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urinary incontinence</keyword>
  <keyword>pelvic floor dysfunction</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sildenafil Citrate</mesh_term>
  </intervention_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/NCT02983461
org study id: 15-0121
nct id: NCT02983461
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The investigators goal is to develop medical treatments for stress/mixed urinary
      incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and
      strength and to decrease muscle fatigue. The investigators believe that it will improve
      muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related
      to pelvic floor dysfunction.
Aim: To determine the effect of sildenafil on urinary incontinence.

        1. Episodes of urinary incontinence will be recorded using a 3 day bladder diary.

        2. Quantitative assessment of urinary incontinence will be performed at baseline and after
           treatment using a Pad Test.

        3. Muscle strength will be assessed through use of a perineometer.

        4. To evaluate macrocirculatory blood flow in pelvic organs, women will be assessed with
           noninvasive imaging before and after randomization to sildenafil.

        5. Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Urinary Incontinence as measured by Pad Test
time frame: 10 weeks
description: Pad tests quantitatively measures urine leakage
arm group label: Placebo
arm group type: Placebo Comparator
description: Double Blind Placebo 3 times a day for 10 weeks.
arm group label: Sildenafil
arm group type: Active Comparator
description: Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.
intervention type: Drug
intervention name: Sildenafil
description: Sildenafil, 20mg x 3 times a day for 10 weeks
arm group label: Sildenafil
intervention type: Drug
intervention name: Placebo
description: Placebo oral tablet, 3 times a day for 10 weeks
arm group label: Placebo
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen L Vincent, MD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Sildenafil Citrate