<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/NCT04491526</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00569</org_study_id>
    <nct_id>NCT04491526</nct_id>
  </id_info>
  <brief_title>Study to Prevent Postoperative Urinary Retention</brief_title>
  <acronym>STOP-POUR</acronym>
  <official_title>Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antonio Nocito, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Baden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair&#xD;
      with a reported incidence up 34%. It can be described as the inability to initiate urination&#xD;
      or properly empty one's bladder following surgery. It is usually self-limited, but it&#xD;
      requires the use of catheterization to empty the bladder in order to prevent further injury&#xD;
      to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a&#xD;
      medication that is commonly used in men with urinary symptoms related to an enlarged&#xD;
      prostate. There is some evidence to suggest that it may also potentially be beneficial for&#xD;
      preventing post-operative urinary retention.&#xD;
&#xD;
      The purpose of this study is to determine if tamsulosin (&quot;TAMSULOSIN Mepha Ret Depocaps 0.4&#xD;
      mg&quot;) is effective in preventing post-operative urinary retention following endoscopic total&#xD;
      extraperitoneal inguinal hernia repair and its impact on hospital length of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this RCT subjects are randomly and parallel assigned to one of two groups: one (the&#xD;
      experimental group) receiving &quot;Tamsulosin 0.4 mg&quot;/ day, 5 days prior to the day of&#xD;
      laparoscopic inguinal hernia repair surgery, at the day of surgery and for 1 day following&#xD;
      surgery. (5+1+1), and the other (the control group) receiving one placebo capsule matching&#xD;
      the active study drug per day from 5 days prior to the day of surgery, at the day of surgery&#xD;
      and for 1 day following surgery. (5+1+1). There will be effective (concealed) randomization&#xD;
      of the subjects to the intervention/control groups (to eliminate selection bias and minimize&#xD;
      confounding variables). Both groups will be treated identically in all respects except for&#xD;
      the intervention being tested and to this end patients, investigators, care providers and&#xD;
      outcomes assessors will be blinded to which group an individual is assigned. Group assignment&#xD;
      will be performed using a covariate-adaptive allocation procedure to provide a balance for&#xD;
      selected covariates (Site, IPSS-Score, Age, &quot;uni- or bilateral surgery&quot; and &quot;history of&#xD;
      prostate or bladder surgery&quot;. To achieve that; Minimization, first described by Taves [and&#xD;
      expanded by Pocock and Simon [the most commonly used covariate-adaptive randomization method&#xD;
      will be applied. It achieves the balance in treatment assignments across factor levels by&#xD;
      choosing the allocation for the new subject that would lead to the smallest degree of&#xD;
      imbalance possible across the set of his baseline characteristics. The two groups are then&#xD;
      followed up to 3 days after surgery to see if there are any differences between them in&#xD;
      primary and secondary outcomes. Patients are analyzed within the group to which they were&#xD;
      allocated, irrespective of whether they experienced the intended intervention (intention to&#xD;
      treat analysis). This RCT is designed as a superiority trial and aims to demonstrate the&#xD;
      superiority of Tamsulosin in prevention of POUR compared to placebo. We anticipate the&#xD;
      detection of a 65% relative risk reduction of POUR in the experimental group in comparison&#xD;
      with the placebo group. To detect a 65% reduction of POUR in the experimental group (2.9%&#xD;
      anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study&#xD;
      power of 80% with a Fisher's Exact Test and a significance level of 5% and adjusting for a&#xD;
      drop-out rate of 2% we need 634 patients in total; 317 in each group. Our target population&#xD;
      consists of male patients ≥ 60 yrs, scheduled for elective endoscopic inguinal hernia repair.&#xD;
      The studied sample is appropriate to the hypothesis being tested so that any results will be&#xD;
      appropriately generalizable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative urinary retention (Need for any catheterization postoperatively)</measure>
    <time_frame>up to 3 days after surgery</time_frame>
    <description>Need for any catheterization postoperatively (Yes/No)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first voiding after surgery</measure>
    <time_frame>up to 3 days after surgery</time_frame>
    <description>secondary outcomes in Non-POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Volume measurement at defined points in time (n)</measure>
    <time_frame>up to 12 hours after surgery</time_frame>
    <description>secondary outcomes in all Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of first micturition after surgery</measure>
    <time_frame>up to 12 hours after surgery</time_frame>
    <description>secondary outcomes in Non-POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain (Quantity of Pain / VAS-Score)</measure>
    <time_frame>up to 3 days after surgery</time_frame>
    <description>Quantity of pain is verified at arrival in the PACU and at every 6 hours by the nursing staff, using the standardised numeric rating scale. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for opioid analgesics post operatively</measure>
    <time_frame>up to 3 days after surgery</time_frame>
    <description>secondary outcomes in all Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)</measure>
    <time_frame>up to 3 days after surgery</time_frame>
    <description>opioid use is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative applications of opioid analgesics (Yes/No)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>Opioid use during surgery is documented in the patient's record, this is a binary endpoint opioid use; (yes/ no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)</measure>
    <time_frame>intra-operative period</time_frame>
    <description>Opioid use during surgery is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of intraoperative fluid administration</measure>
    <time_frame>intra-operative period</time_frame>
    <description>Intraoperative fluid administration (in milliliter) is documented in the patient's record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Prostate Symptom Score (IPSS score) pre-surgery (-5d)</measure>
    <time_frame>min. 5 days prior to surgery</time_frame>
    <description>0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Prostate Symptom Score (IPSS score) post-surgery (3d)</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)</measure>
    <time_frame>5 days prior to surgery (-5d) to day 3(+3d) after surgery</time_frame>
    <description>Will be documented in the patient record by the study personnel, binary endpoint (Yes/No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )</measure>
    <time_frame>as long as the patient is labeled inpatient, on average 1-3 days</time_frame>
    <description>secondary outcomes in all Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay in days (Inpatients)</measure>
    <time_frame>as long as the patient is labeled inpatient, on average 1-3 days</time_frame>
    <description>secondary outcomes in all Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge after surgery in hours (outpatients)</measure>
    <time_frame>up to 12 hours after surgery</time_frame>
    <description>secondary outcomes in all Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual urinary volume after catherization</measure>
    <time_frame>up to 12 hours after surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macrohematuria</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter-related infections</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostatitis</measure>
    <time_frame>3 days post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).</measure>
    <time_frame>1 day post surgery</time_frame>
    <description>secondary outcomes in POUR Patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">634</enrollment>
  <condition>Urinary Retention</condition>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Tamsulosin Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>p.o.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>p.o.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAMSULOSIN Mepha Ret Depocaps 0.4 mg</intervention_name>
    <description>0.4mg/day Tamsulosin hydrochloride (&quot;TAMSULOSIN Mepha Ret Depocaps 0.4 mg&quot;) from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)</description>
    <arm_group_label>Tamsulosin Arm</arm_group_label>
    <other_name>Verum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Intervention</intervention_name>
    <description>One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)</description>
    <arm_group_label>Placebo Arm</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  ≥60 years old&#xD;
&#xD;
          -  Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair&#xD;
&#xD;
          -  Surgery scheduled more than 6 days from the time of consent&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying&#xD;
             position)&#xD;
&#xD;
          -  Severe liver disease (Child Pugh C)&#xD;
&#xD;
          -  Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin,&#xD;
             ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)&#xD;
&#xD;
          -  Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin,&#xD;
             phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker&#xD;
             (duodart)&#xD;
&#xD;
          -  History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin,&#xD;
             doxazosin, prazosin, terazosin, or phenoxybenzamine)&#xD;
&#xD;
          -  Long term Indwelling urinary or suprapubic catheter&#xD;
&#xD;
          -  Status post cystectomy&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse,&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant,&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study,&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Nocito, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uwe Bieri, MD</last_name>
    <phone>+4179 268 78 37</phone>
    <email>uwe.bieri@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juliette Slieker, MD</last_name>
    <phone>+41 (056) 486 10 20</phone>
    <email>Juliette.Slieker@ksb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kantonsspital Baden</name>
      <address>
        <city>Baden</city>
        <state>Aargau</state>
        <zip>5404</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliette Slieker, MD</last_name>
      <phone>+41 56 486 10 20</phone>
      <email>juliette.slieker@ksb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Uwe Bieri, MD</last_name>
      <phone>+41792687837</phone>
      <email>uwe.bieri@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Baden</investigator_affiliation>
    <investigator_full_name>Antonio Nocito, MD</investigator_full_name>
    <investigator_title>Professor Antonio Nocito, Director of the Department of General, Visceral and Vascular Surgery and Chief Physician Surgery</investigator_title>
  </responsible_party>
  <keyword>Urinary Retention</keyword>
  <keyword>Inguinal Hernia Repair</keyword>
  <keyword>alpha-1 adrenergic receptor antagonists</keyword>
  <keyword>IPSS</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>Yes</sharing_ipd>
    <ipd_description>Deidentified participant data are available upon reasonable request from https://orcid.org/0000-0002-7339-1458.</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/NCT04491526
org study id: 2020-00569
nct id: NCT04491526
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair
      with a reported incidence up 34%. It can be described as the inability to initiate urination
      or properly empty one's bladder following surgery. It is usually self-limited, but it
      requires the use of catheterization to empty the bladder in order to prevent further injury
      to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a
      medication that is commonly used in men with urinary symptoms related to an enlarged
      prostate. There is some evidence to suggest that it may also potentially be beneficial for
      preventing post-operative urinary retention.

      The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4
      mg") is effective in preventing post-operative urinary retention following endoscopic total
      extraperitoneal inguinal hernia repair and its impact on hospital length of stay.
In this RCT subjects are randomly and parallel assigned to one of two groups: one (the
      experimental group) receiving "Tamsulosin 0.4 mg"/ day, 5 days prior to the day of
      laparoscopic inguinal hernia repair surgery, at the day of surgery and for 1 day following
      surgery. (5+1+1), and the other (the control group) receiving one placebo capsule matching
      the active study drug per day from 5 days prior to the day of surgery, at the day of surgery
      and for 1 day following surgery. (5+1+1). There will be effective (concealed) randomization
      of the subjects to the intervention/control groups (to eliminate selection bias and minimize
      confounding variables). Both groups will be treated identically in all respects except for
      the intervention being tested and to this end patients, investigators, care providers and
      outcomes assessors will be blinded to which group an individual is assigned. Group assignment
      will be performed using a covariate-adaptive allocation procedure to provide a balance for
      selected covariates (Site, IPSS-Score, Age, "uni- or bilateral surgery" and "history of
      prostate or bladder surgery". To achieve that; Minimization, first described by Taves [and
      expanded by Pocock and Simon [the most commonly used covariate-adaptive randomization method
      will be applied. It achieves the balance in treatment assignments across factor levels by
      choosing the allocation for the new subject that would lead to the smallest degree of
      imbalance possible across the set of his baseline characteristics. The two groups are then
      followed up to 3 days after surgery to see if there are any differences between them in
      primary and secondary outcomes. Patients are analyzed within the group to which they were
      allocated, irrespective of whether they experienced the intended intervention (intention to
      treat analysis). This RCT is designed as a superiority trial and aims to demonstrate the
      superiority of Tamsulosin in prevention of POUR compared to placebo. We anticipate the
      detection of a 65% relative risk reduction of POUR in the experimental group in comparison
      with the placebo group. To detect a 65% reduction of POUR in the experimental group (2.9%
      anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study
      power of 80% with a Fisher's Exact Test and a significance level of 5% and adjusting for a
      drop-out rate of 2% we need 634 patients in total; 317 in each group. Our target population
      consists of male patients ≥ 60 yrs, scheduled for elective endoscopic inguinal hernia repair.
      The studied sample is appropriate to the hypothesis being tested so that any results will be
      appropriately generalizable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Post operative urinary retention (Need for any catheterization postoperatively)
time frame: up to 3 days after surgery
description: Need for any catheterization postoperatively (Yes/No)
measure: Time to first voiding after surgery
time frame: up to 3 days after surgery
description: secondary outcomes in Non-POUR Patients
measure: Urinary Volume measurement at defined points in time (n)
time frame: up to 12 hours after surgery
description: secondary outcomes in all Patients
measure: Volume of first micturition after surgery
time frame: up to 12 hours after surgery
description: secondary outcomes in Non-POUR Patients
measure: Post-operative Pain (Quantity of Pain / VAS-Score)
time frame: up to 3 days after surgery
description: Quantity of pain is verified at arrival in the PACU and at every 6 hours by the nursing staff, using the standardised numeric rating scale. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older.
measure: Need for opioid analgesics post operatively
time frame: up to 3 days after surgery
description: secondary outcomes in all Patients
measure: Quantity of post-operative opioid use (opioid dosage will be converted to oral morphine equivalence dose)
time frame: up to 3 days after surgery
description: opioid use is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
measure: Intraoperative applications of opioid analgesics (Yes/No)
time frame: intra-operative period
description: Opioid use during surgery is documented in the patient's record, this is a binary endpoint opioid use; (yes/ no)
measure: Quantity of intra-operative opioid use opioid dosage will be converted to oral morphine equivalence dose)
time frame: intra-operative period
description: Opioid use during surgery is documented in the patient's record, opioid dosage will be converted to oral morphine equivalence dose
measure: Amount of intraoperative fluid administration
time frame: intra-operative period
description: Intraoperative fluid administration (in milliliter) is documented in the patient's record
measure: International Prostate Symptom Score (IPSS score) pre-surgery (-5d)
time frame: min. 5 days prior to surgery
description: 0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
measure: International Prostate Symptom Score (IPSS score) post-surgery (3d)
time frame: 3 days post surgery
description: 0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
measure: Change in International Prostate Symptom Score (IPSS score) from baseline prior to surgery (-5d) to day 3(+3d) after surgery
time frame: 3 days post surgery
description: 0-7 Mildly symptomatic / 8-19 Moderately symptomatic / 20-35 Severely symptomatic
measure: Side-effects of study medication (orthostatic hypotension, retrograde ejaculation, Floppy-Iris-Syndrom)
time frame: 5 days prior to surgery (-5d) to day 3(+3d) after surgery
description: Will be documented in the patient record by the study personnel, binary endpoint (Yes/No)
measure: In hospital complications (using the evaluated standard classification for complication in surgery (Classification Grade I-V) )
time frame: as long as the patient is labeled inpatient, on average 1-3 days
description: secondary outcomes in all Patients
measure: Length of hospital stay in days (Inpatients)
time frame: as long as the patient is labeled inpatient, on average 1-3 days
description: secondary outcomes in all Patients
measure: Time to discharge after surgery in hours (outpatients)
time frame: up to 12 hours after surgery
description: secondary outcomes in all Patients
measure: Residual urinary volume after catherization
time frame: up to 12 hours after surgery
description: secondary outcomes in POUR Patients
measure: Macrohematuria
time frame: 3 days post surgery
description: secondary outcomes in POUR Patients
measure: Relevant injury to the urethra (Presence of a Via falsa diagnosed by a urologist)
time frame: 3 days post surgery
description: secondary outcomes in POUR Patients
measure: Catheter-related infections
time frame: 3 days post surgery
description: secondary outcomes in POUR Patients
measure: Catheter-related bladder discomfort ( (Ggrading according to the 3three Ggrades (mild, moderate, severe)
time frame: 3 days post surgery
description: secondary outcomes in POUR Patients
measure: Prostatitis
time frame: 3 days post surgery
description: secondary outcomes in POUR Patients
measure: Failed first trial without catheter (TWOC: need for a second catheter insertion due to insufficient voiding after TWOC).
time frame: 1 day post surgery
description: secondary outcomes in POUR Patients
arm group label: Tamsulosin Arm
arm group type: Experimental
description: p.o.
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: p.o.
intervention type: Drug
intervention name: TAMSULOSIN Mepha Ret Depocaps 0.4 mg
description: 0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
arm group label: Tamsulosin Arm
other name: Verum
intervention type: Drug
intervention name: Control Intervention
description: One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
arm group label: Placebo Arm
other name: Placebo
criteria: 
gender: Male
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Nocito, Prof
role: Principal Investigator
affiliation: Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland
last name: Uwe Bieri, MD
phone: +4179 268 78 37
email: uwe.bieri@gmail.com
last name: Juliette Slieker, MD
phone: +41 (056) 486 10 20
email: Juliette.Slieker@ksb.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Kantonsspital Baden
investigator full name: Antonio Nocito, MD
investigator title: Professor Antonio Nocito, Director of the Department of General, Visceral and Vascular Surgery and Chief Physician Surgery
mesh term: Urinary Retention
mesh term: Hernia
mesh term: Hernia, Inguinal
mesh term: Tamsulosin
sharing ipd: Yes
ipd description: Deidentified participant data are available upon reasonable request from https://orcid.org/0000-0002-7339-1458.