<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/NCT03027115</url>
  </required_header>
  <id_info>
    <org_study_id>MHUMC 2016.10.05</org_study_id>
    <nct_id>NCT03027115</nct_id>
  </id_info>
  <brief_title>Hernia Surgery Urinary Retention</brief_title>
  <official_title>Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Health University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Health University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist&#xD;
      affects the likelihood of male patients developing post-operative urinary retention following&#xD;
      hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study will be to investigate whether pre-operative treatment with a&#xD;
      selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing&#xD;
      post-operative urinary retention following hernia repair surgery. It is also of interest to&#xD;
      determine whether or not a well-known urological screening tool, the IPSS, can identify&#xD;
      patients at risk for urinary retention following elective laparoscopic or open hernia repair&#xD;
      surgery. We will investigate if it is possible to pre-treat patients with a selective&#xD;
      alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative&#xD;
      urinary retention and the associated adverse consequences, especially in those patients at&#xD;
      higher risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Anticipated">January 27, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 13, 2020</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>
    <intervention_model_description>Randomization to 1 of 2 possible arms, control and treatment</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative urinary retention</measure>
    <time_frame>2 weeks</time_frame>
    <description>Incidence of post-operative urinary retention in patients undergoing hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of IPSS</measure>
    <time_frame>2 weeks</time_frame>
    <description>the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Hernia</condition>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment with a selective alpha1-adrenoceptor antagonist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <description>Tamsulosin treatment for 7 days pre-operatively</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Flomax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Presenting with hernia requiring surgical intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerability of tamsulosin or related drugs&#xD;
&#xD;
          -  Investigator discretion&#xD;
&#xD;
          -  Unwillingness or inability to comply with protocol procedures and assessments&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vishu Danthuluri, M.D.</last_name>
    <phone>256.665-6214</phone>
    <email>vishwanathdanthuluri@memorialhealth.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrew Schwemmer, M.D.</last_name>
    <email>SchweAn2@memorialhealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vishu Danthuluri, M.D.</last_name>
      <phone>256-665-5214</phone>
      <email>vishwanathdanthuluri@memorialhealth.com</email>
    </contact>
    <contact_backup>
      <last_name>Andrew Schwemmer, M.D.</last_name>
      <email>SchweAn2@memorialhealth.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</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 Retention</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD.</ipd_description>
  </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/NCT03027115
org study id: MHUMC 2016.10.05
nct id: NCT03027115
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist
      affects the likelihood of male patients developing post-operative urinary retention following
      hernia repair.
The purpose of this study will be to investigate whether pre-operative treatment with a
      selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing
      post-operative urinary retention following hernia repair surgery. It is also of interest to
      determine whether or not a well-known urological screening tool, the IPSS, can identify
      patients at risk for urinary retention following elective laparoscopic or open hernia repair
      surgery. We will investigate if it is possible to pre-treat patients with a selective
      alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative
      urinary retention and the associated adverse consequences, especially in those patients at
      higher risk.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization to 1 of 2 possible arms, control and treatment
primary purpose: Prevention
masking: None (Open Label)
measure: Post-operative urinary retention
time frame: 2 weeks
description: Incidence of post-operative urinary retention in patients undergoing hernia repair
measure: Effect of IPSS
time frame: 2 weeks
description: the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS)
arm group label: Treatment
arm group type: Experimental
description: treatment with a selective alpha1-adrenoceptor antagonist
arm group label: Control
arm group type: No Intervention
description: no treatment
intervention type: Drug
intervention name: Tamsulosin
description: Tamsulosin treatment for 7 days pre-operatively
arm group label: Treatment
other name: Flomax
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vishu Danthuluri, M.D.
phone: 256.665-6214
email: vishwanathdanthuluri@memorialhealth.com
last name: Andrew Schwemmer, M.D.
email: SchweAn2@memorialhealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Retention
mesh term: Hernia
mesh term: Tamsulosin
sharing ipd: No
ipd description: There is no plan to share IPD.