<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/NCT01661166</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 15810</org_study_id>
    <nct_id>NCT01661166</nct_id>
  </id_info>
  <brief_title>A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy</brief_title>
  <official_title>A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy )</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity&#xD;
      (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and&#xD;
      to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.&#xD;
      Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 15, 2013</completion_date>
  <primary_completion_date type="Actual">April 15, 2013</primary_completion_date>
  <phase>Phase 4</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>Number of Adverse Events</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Fesoterodine 4mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fesoterodine 4mg, Oral once daily for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Oral once daily for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine</intervention_name>
    <description>4 mg</description>
    <arm_group_label>Fesoterodine 4mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral tablet</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 30 to 90 years old with prostate adenocarcinoma who have already made their&#xD;
             treatment selection of RARP, and only men with an AUA symptom score greater than 7&#xD;
             will be included. All subjects must be able to read and comprehend fully the informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men with prostate neoplasms other than adenocarcinoma&#xD;
&#xD;
          -  Subjects receiving other treatments for prostate cancer will be excluded.&#xD;
&#xD;
          -  Any subject with a preexisting bladder disease will be excluded.&#xD;
&#xD;
          -  Subjects with acute urinary retention and/or deceased gastrointestinal motility.&#xD;
&#xD;
          -  Subjects with glaucoma.&#xD;
&#xD;
          -  Subjects with hepatic or renal impairment.&#xD;
&#xD;
          -  Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, itraconazole, clarithromycin).&#xD;
&#xD;
          -  Subjects with myasthenia gravis&#xD;
&#xD;
          -  Subjects who are unwilling or unable to complete the subject questionnaires&#xD;
&#xD;
          -  Subjects, who in the opinion of the investigator, would be non-compliant with the&#xD;
             majority of the visits scheduled or study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <disposition_first_submitted>April 6, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>April 24, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 28, 2020</disposition_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Male adult subjects</keyword>
  <keyword>aged 30-90 years</keyword>
  <keyword>RARP</keyword>
  <keyword>American Urological Association symptom score greater than 7 will be included</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fesoterodine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01661166
org study id: UPCC 15810
nct id: NCT01661166
lead sponsor: 
has dmc: Yes
The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity
      (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and
      to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.
      Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Adverse Events
time frame: 3 months
arm group label: Fesoterodine 4mg
arm group type: Experimental
description: Fesoterodine 4mg, Oral once daily for three months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Oral once daily for three months
intervention type: Drug
intervention name: Fesoterodine
description: 4 mg
arm group label: Fesoterodine 4mg
intervention type: Drug
intervention name: Placebo oral tablet
description: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
last name: David Lee, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Fesoterodine