<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/NCT03808155</url>
  </required_header>
  <id_info>
    <org_study_id>GR20192021</org_study_id>
    <nct_id>NCT03808155</nct_id>
  </id_info>
  <brief_title>Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty</brief_title>
  <official_title>Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Graubünden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Graubünden</source>
  <oversight_info>
    <has_dmc>No</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>
      Various studies have shown that the risk of suffering a urinary retention after knee or hip&#xD;
      prosthesis surgery is 10-80%. The aim of the study is to reduce this riks. For this purpose,&#xD;
      it is investigated whether a previously known drug (tamsulosin) which is used in bladder&#xD;
      emptying disorders, can achieve a reduction in urinary retention after surgery. After the&#xD;
      patients agree to participate in the study, they are examined in our urological clinic.&#xD;
      Uroflowmetry is performed with sonographic residual volume measurement and prostate volume&#xD;
      measurement. Furthermore, a standardized Voiding questionaire (IPSS) is completed. This study&#xD;
      is conducted as a double-blind study using a placebo control group. The drug / placebo is&#xD;
      taken once a day, five days before and two days after surgery. Subsequently, it is observed&#xD;
      whether it comes to a urinary retention or not. After the operation, no further urological&#xD;
      checks are planned or needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Category and rationale:&#xD;
&#xD;
      This study uses a well-known drug (tamsulosin) which is authorised in Switzerland and widely&#xD;
      used to treat obstructive voiding problems. In our case the indication is different from that&#xD;
      specified in the prescribing information, but it is within the same disease group, which in&#xD;
      our case is to prevent urinary retention. Therefore according to the legal ordinance on&#xD;
      clinical trials (ClinO), this study is classified as a clinical trial, research with&#xD;
      collection of health-related personal data and placebo controlled of the category B.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      Our goal is to reduce the rate of postoperative urinary retention after lower limb&#xD;
      arthroplasty. For this purpose, we plan to investigate whether an already known drug&#xD;
      (Tamsulosin), which is widely used for bladder emptying disorders, could reduce the rate of&#xD;
      postoperative urinary retention.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.&#xD;
      The secondary outcome is the influence of other clinical factors on the occurrence of urinary&#xD;
      retention as type of anaesthesia, preoperative residual volume, prostate size and&#xD;
      international prostate symptom score (IPSS).&#xD;
&#xD;
      Measurement and procedures:&#xD;
&#xD;
      Once the decision for lower limb arthroplasty is made during the planned orthopaedic&#xD;
      consultation, the patient will receive a participant information sheet and the informed&#xD;
      consent. If the patient is interested to take part in the study he will receive an&#xD;
      appointment in the urological clinic at least six days before the operation. During the&#xD;
      appointment a urological specialist will explain the entire study. A uroflowmetry with&#xD;
      sonographic measurement of residual volume and prostate volume will be performed.&#xD;
      Furthermore, the patient will fill out an IPSS-questionnaire. After the appointment the&#xD;
      drug/placebo will be handed out to the patient, which should be taken once a day five days&#xD;
      prior to the operation, on the day of surgery and two days thereafter.&#xD;
&#xD;
      Study product:&#xD;
&#xD;
      The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five&#xD;
      days prior to the operation and two days after the operation.&#xD;
&#xD;
      Control intervention:&#xD;
&#xD;
      Placebo.&#xD;
&#xD;
      Number of participants with rationale:&#xD;
&#xD;
      The number of participants projected for the entire study is 170. Thus 85 patients in the&#xD;
      drug-treatment group and 85 patients for the placebo-treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <masking_description>Double blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of urinary retention</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of anaesthesia</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative residual volume</measure>
    <time_frame>Minimum 6 days before the planned operation.</time_frame>
    <description>Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate size</measure>
    <time_frame>Minimum 6 days before the planned operation.</time_frame>
    <description>Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International prostate symptom score (IPSS).</measure>
    <time_frame>Minimum 6 days before the planned operation.</time_frame>
    <description>The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Urinary Retention Postoperative</condition>
  <condition>Arthropathy of Knee</condition>
  <condition>Arthropathy of Hip</condition>
  <arm_group>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five days prior to the operation and two days after the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo is taken once a day per os five days prior to the operation and two days after the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <description>The drug ist taken once a day per os five days prior to the operation and two days after the operation.</description>
    <arm_group_label>Tamsulosin</arm_group_label>
    <other_name>Pradif</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>The placebo ist taken once a day per os five days prior to the operation and two days after the operation.</description>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - male adults undergoing elective hip- or knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women&#xD;
&#xD;
          -  underage patients&#xD;
&#xD;
          -  pre-existing treatment with tamsulosin or other prostate affecting medication&#xD;
&#xD;
          -  patients who underwent transurethral resection of the prostate or prostatectomy&#xD;
&#xD;
          -  patients with urethral strictures&#xD;
&#xD;
          -  patients with neurological bladder dysfunction&#xD;
&#xD;
          -  Known allergy to tamsulosin&#xD;
&#xD;
          -  Hypotensive disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The participant has to be a genectic male with all male organs.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Räto T. Strebel, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Graubünden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Räto T. Strebel, PD Dr. med.</last_name>
    <phone>+41 81 256 62 35</phone>
    <email>raeto.strebel@ksgr.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kantonsspital Graubünden</name>
      <address>
        <city>Chur</city>
        <state>Graubünden</state>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Räto T Strebel, PD Dr. med.</last_name>
      <phone>+41812566237</phone>
      <email>raeto.strebel@ksgr.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Graubünden</investigator_affiliation>
    <investigator_full_name>PD Dr. med. Räto T. Strebel</investigator_full_name>
    <investigator_title>Head of Urology</investigator_title>
  </responsible_party>
  <keyword>Urinary retention</keyword>
  <keyword>Tamsulosin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Urinary Retention</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/NCT03808155
org study id: GR20192021
nct id: NCT03808155
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Various studies have shown that the risk of suffering a urinary retention after knee or hip
      prosthesis surgery is 10-80%. The aim of the study is to reduce this riks. For this purpose,
      it is investigated whether a previously known drug (tamsulosin) which is used in bladder
      emptying disorders, can achieve a reduction in urinary retention after surgery. After the
      patients agree to participate in the study, they are examined in our urological clinic.
      Uroflowmetry is performed with sonographic residual volume measurement and prostate volume
      measurement. Furthermore, a standardized Voiding questionaire (IPSS) is completed. This study
      is conducted as a double-blind study using a placebo control group. The drug / placebo is
      taken once a day, five days before and two days after surgery. Subsequently, it is observed
      whether it comes to a urinary retention or not. After the operation, no further urological
      checks are planned or needed.
Study Category and rationale:

      This study uses a well-known drug (tamsulosin) which is authorised in Switzerland and widely
      used to treat obstructive voiding problems. In our case the indication is different from that
      specified in the prescribing information, but it is within the same disease group, which in
      our case is to prevent urinary retention. Therefore according to the legal ordinance on
      clinical trials (ClinO), this study is classified as a clinical trial, research with
      collection of health-related personal data and placebo controlled of the category B.

      Objective:

      Our goal is to reduce the rate of postoperative urinary retention after lower limb
      arthroplasty. For this purpose, we plan to investigate whether an already known drug
      (Tamsulosin), which is widely used for bladder emptying disorders, could reduce the rate of
      postoperative urinary retention.

      Outcomes:

      The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
      The secondary outcome is the influence of other clinical factors on the occurrence of urinary
      retention as type of anaesthesia, preoperative residual volume, prostate size and
      international prostate symptom score (IPSS).

      Measurement and procedures:

      Once the decision for lower limb arthroplasty is made during the planned orthopaedic
      consultation, the patient will receive a participant information sheet and the informed
      consent. If the patient is interested to take part in the study he will receive an
      appointment in the urological clinic at least six days before the operation. During the
      appointment a urological specialist will explain the entire study. A uroflowmetry with
      sonographic measurement of residual volume and prostate volume will be performed.
      Furthermore, the patient will fill out an IPSS-questionnaire. After the appointment the
      drug/placebo will be handed out to the patient, which should be taken once a day five days
      prior to the operation, on the day of surgery and two days thereafter.

      Study product:

      The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five
      days prior to the operation and two days after the operation.

      Control intervention:

      Placebo.

      Number of participants with rationale:

      The number of participants projected for the entire study is 170. Thus 85 patients in the
      drug-treatment group and 85 patients for the placebo-treatment group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind.
measure: Occurrence of urinary retention
time frame: 48 hours postoperatively
description: The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
measure: Type of anaesthesia
time frame: 48 hours postoperatively
description: Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia
measure: Preoperative residual volume
time frame: Minimum 6 days before the planned operation.
description: Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.
measure: Prostate size
time frame: Minimum 6 days before the planned operation.
description: Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.
measure: International prostate symptom score (IPSS).
time frame: Minimum 6 days before the planned operation.
description: The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
arm group label: Tamsulosin
arm group type: Active Comparator
description: The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five days prior to the operation and two days after the operation.
arm group label: Placebo Oral Tablet
arm group type: Placebo Comparator
description: The placebo is taken once a day per os five days prior to the operation and two days after the operation.
intervention type: Drug
intervention name: Tamsulosin
description: The drug ist taken once a day per os five days prior to the operation and two days after the operation.
arm group label: Tamsulosin
other name: Pradif
intervention type: Drug
intervention name: Placebo Oral Tablet
description: The placebo ist taken once a day per os five days prior to the operation and two days after the operation.
arm group label: Placebo Oral Tablet
criteria: 
gender: Male
gender based: Yes
gender description: The participant has to be a genectic male with all male organs.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Räto T. Strebel, PD Dr. med.
role: Principal Investigator
affiliation: Kantonsspital Graubünden
last name: Räto T. Strebel, PD Dr. med.
phone: +41 81 256 62 35
email: raeto.strebel@ksgr.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Graubünden
investigator full name: PD Dr. med. Räto T. Strebel
investigator title: Head of Urology
mesh term: Joint Diseases
mesh term: Urinary Retention
mesh term: Tamsulosin
sharing ipd: No