<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/NCT04434378</url>
  </required_header>
  <id_info>
    <org_study_id>17-19</org_study_id>
    <nct_id>NCT04434378</nct_id>
  </id_info>
  <brief_title>Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair</brief_title>
  <official_title>The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish Hospital, Cincinnati, Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jewish Hospital, Cincinnati, Ohio</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of tamsulosin on the development of post-operative urinary&#xD;
      retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be&#xD;
      accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the&#xD;
      rate of urinary retention necessitating straight catheterization or insertion of foley&#xD;
      catheter prior to discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented&#xD;
      in the office by the attending physician. An order will be placed during surgery scheduling&#xD;
      for tamsulosin with instruction to administer one dose in the preoperative holding area on&#xD;
      the day of surgery. The Jewish hospital pharmacy will be responsible for providing&#xD;
      randomization and placebo medications for double blinding effect. PUR will be tracked on the&#xD;
      basis of urinary catheterization performed prior to hospital discharge. Criteria for&#xD;
      catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder&#xD;
      scan showing &gt;400 mL. ii) Inability to urinate at any time postoperatively with symptoms of&#xD;
      urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to&#xD;
      have a confirmed negative urine or serum pregnancy test prior to surgery. This will be&#xD;
      completed on arrival to the preoperative holding area.&#xD;
&#xD;
      To detect the difference between the treated group and control group with a significant alpha&#xD;
      (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated&#xD;
      using the Pearson Chi-square test for Two proportions.&#xD;
&#xD;
      This study will be conducted in the hospital setting at a single institution. Patients will&#xD;
      be consented for the study in the pre-admission holding area and followed until discharged&#xD;
      from the post anesthesia care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Significant difference not reached on interim analysis&#xD;
  </why_stopped>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 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>One group will be randomized to tamsulosin and the second group randomized to placebo</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of postoperative urinary retention.</measure>
    <time_frame>Within 24 hours of surgery</time_frame>
    <description>Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing &gt;400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.</measure>
    <time_frame>within 24 hours of surgery</time_frame>
    <description>Retrospective chart review will be utilized to asses the incidence of risk factors of postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. Risk factors including age &gt;60, total IV fluids, length of procedure, opioid use, bilateral vs unilateral repair, BMI &gt;30, diabetes mellitus, coronary artery disease, and benign prostatic hyperplasia will be assessed. These risk factors will then undergo statistical analysis to determine if they are associated with postoperative urinary retention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Post Operative Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <description>0.4 mg tamsulosin will be given to a randomized group of patients</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo will be given to a randomized group of patients</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or&#xD;
             bilateral.&#xD;
&#xD;
          2. ≥18 years of age.&#xD;
&#xD;
          3. Patients must leave the operating room without at indwelling urinary catheter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of neurogenic bladder requiring routine intermittent catheterization&#xD;
&#xD;
          2. Emergent laparoscopic hernia repair.&#xD;
&#xD;
          3. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g.&#xD;
             nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling&#xD;
             urinary catheter in the postoperative period.&#xD;
&#xD;
          4. Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jewish Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.</citation>
    <PMID>18813990</PMID>
  </reference>
  <reference>
    <citation>Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.</citation>
    <PMID>22741052</PMID>
  </reference>
  <reference>
    <citation>Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.</citation>
    <PMID>25935942</PMID>
  </reference>
  <reference>
    <citation>Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.</citation>
    <PMID>24200291</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish Hospital, Cincinnati, Ohio</investigator_affiliation>
    <investigator_full_name>Michael Caparelli</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>laparoscopic inguinal hernia repair</keyword>
  <keyword>tamsulosin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</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>
  </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/NCT04434378
org study id: 17-19
nct id: NCT04434378
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To investigate the effect of tamsulosin on the development of post-operative urinary
      retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be
      accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the
      rate of urinary retention necessitating straight catheterization or insertion of foley
      catheter prior to discharge.
Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented
      in the office by the attending physician. An order will be placed during surgery scheduling
      for tamsulosin with instruction to administer one dose in the preoperative holding area on
      the day of surgery. The Jewish hospital pharmacy will be responsible for providing
      randomization and placebo medications for double blinding effect. PUR will be tracked on the
      basis of urinary catheterization performed prior to hospital discharge. Criteria for
      catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder
      scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of
      urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to
      have a confirmed negative urine or serum pregnancy test prior to surgery. This will be
      completed on arrival to the preoperative holding area.

      To detect the difference between the treated group and control group with a significant alpha
      (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated
      using the Pearson Chi-square test for Two proportions.

      This study will be conducted in the hospital setting at a single institution. Patients will
      be consented for the study in the pre-admission holding area and followed until discharged
      from the post anesthesia care unit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group will be randomized to tamsulosin and the second group randomized to placebo
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of postoperative urinary retention.
time frame: Within 24 hours of surgery
description: Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort).
measure: Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.
time frame: within 24 hours of surgery
description: Retrospective chart review will be utilized to asses the incidence of risk factors of postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair. Risk factors including age >60, total IV fluids, length of procedure, opioid use, bilateral vs unilateral repair, BMI >30, diabetes mellitus, coronary artery disease, and benign prostatic hyperplasia will be assessed. These risk factors will then undergo statistical analysis to determine if they are associated with postoperative urinary retention.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.
arm group label: Interventional
arm group type: Experimental
description: Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery.
intervention type: Drug
intervention name: Tamsulosin
description: 0.4 mg tamsulosin will be given to a randomized group of patients
arm group label: Interventional
intervention type: Drug
intervention name: Placebo
description: placebo will be given to a randomized group of patients
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
PMID: 18813990
citation: Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.
PMID: 22741052
citation: Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.
PMID: 25935942
citation: Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.
PMID: 24200291
responsible party type: Principal Investigator
investigator affiliation: Jewish Hospital, Cincinnati, Ohio
investigator full name: Michael Caparelli
investigator title: Resident
mesh term: Urinary Retention
mesh term: Hernia
mesh term: Hernia, Inguinal
mesh term: Tamsulosin
sharing ipd: No