<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/NCT02196987</url>
  </required_header>
  <id_info>
    <org_study_id>109/14</org_study_id>
    <nct_id>NCT02196987</nct_id>
  </id_info>
  <brief_title>Does the Act of Urination During Urethral Catheterisation in Males Reduce Pain?</brief_title>
  <official_title>Pain Level During Male Urethral Catheterisation - Does Patient Attempted Urination During Catheterisation Reduce Pain? A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, there are no specific guidelines or best practice suggestions for best male&#xD;
      catheterization as fat as insertion technique. There is however, information as to reducing&#xD;
      infection, and as to recommended lubricant.&#xD;
&#xD;
      From our experience, the investigators have noticed that when requesting the patient to&#xD;
      attempt urination while inserting a urethral catheter, the level of pain and discomfort is&#xD;
      reduced. In this study, the investigators will evaluate the pain level during male urethral&#xD;
      catheterization in each technique.&#xD;
&#xD;
      Our hypothesis is that the level of pain will be much less if the in the study group where&#xD;
      the act of urination will be requested from the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized prospective study that will compare the pain levels of urethral&#xD;
      catheterization in men randomized to requesting to urinate while inserting a urethral&#xD;
      catheter to normal catheter insertion.&#xD;
&#xD;
      Males aged 18 years and older who will be referred for multichannel Urodynamic study in order&#xD;
      to evaluate lower urinary tract symptoms will be included.&#xD;
&#xD;
      Patients will be randomized to 2 groups: (1) Patients who will be requested to urinate while&#xD;
      catheterising the urethra to its full length; (2), Patients who will be requested to lie&#xD;
      while catheterising the urethra, without further instructions from the medical professional.&#xD;
      In both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the&#xD;
      urethra. The randomization technique will be employed by a computerized random number&#xD;
      generator.&#xD;
&#xD;
      A 12F Tieman urethral catheter will be introduced in order to measure post-void residual&#xD;
      volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch&#xD;
      Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling&#xD;
      will be carried out using room temperature saline at a filling rate of 50 ml/min.&#xD;
&#xD;
      Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual&#xD;
      analog pain scale (VAS) in different time points: before the procedure (baseline),&#xD;
      immediately after gel instillation, immediately after the introduction of the Tieman&#xD;
      catheter, 15 minutes after the catheter will be taken out.&#xD;
&#xD;
      Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the&#xD;
      study evaluates pain during the procedure the time frame of the study and assessment is very&#xD;
      short. longer follow-up is not needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in visual analog pain scales</measure>
    <time_frame>Before catheterisation, during catheterisation, 15 minutes after catheterisation</time_frame>
    <description>A 0 to 10 visual analog pain scale (VAS)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Urination, urethral catheterisation</arm_group_label>
    <description>Act of urination during urethral catheterisation in males</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lie, catheterisation, urethra</arm_group_label>
    <description>Urethral catheterisation without medical professional guidance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urination during urethral catheterisation</intervention_name>
    <description>Requesting the patient to urinate while inserting urethral catheter</description>
    <arm_group_label>Urination, urethral catheterisation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urethral catheterisation, without further guidance</intervention_name>
    <description>Lying, inserting urethral catheter, without further guidance from health care professional</description>
    <arm_group_label>Lie, catheterisation, urethra</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men who will be referred to Urodynamic study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men aged 18 years and older who will be referred for multichannel Urodynamic study in&#xD;
             order to evaluate lower urinary tract symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of any analgesics within the previous 24 hours, known urethral stricture, active&#xD;
             urinary tract infection, indwelling urethral catheter, pre-existing urethral pain&#xD;
             (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis),&#xD;
             inability to cooperate with pain assessment due to mental disorders.&#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_official>
    <last_name>Kobi Stav, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf Harofe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kobi Stav, MD</last_name>
    <phone>972-8-9778461</phone>
    <email>stavkobi@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assaf Harofe Medical Center</name>
      <address>
        <city>Beer Yaakov, Zeriffin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kobi Stav, MD</last_name>
      <phone>972-8-9778461</phone>
      <email>stavkobi@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Kobi Stav, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assaf-Harofeh Medical Center</investigator_affiliation>
    <investigator_full_name>Assaf Harofeh MC</investigator_full_name>
    <investigator_title>Dr. Kobi Stav</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Catheter</keyword>
  <keyword>Urethra</keyword>
  <keyword>Urination</keyword>
  <!-- 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/NCT02196987
org study id: 109/14
nct id: NCT02196987
lead sponsor: 
has dmc: No
Currently, there are no specific guidelines or best practice suggestions for best male
      catheterization as fat as insertion technique. There is however, information as to reducing
      infection, and as to recommended lubricant.

      From our experience, the investigators have noticed that when requesting the patient to
      attempt urination while inserting a urethral catheter, the level of pain and discomfort is
      reduced. In this study, the investigators will evaluate the pain level during male urethral
      catheterization in each technique.

      Our hypothesis is that the level of pain will be much less if the in the study group where
      the act of urination will be requested from the patient.
This is a randomized prospective study that will compare the pain levels of urethral
      catheterization in men randomized to requesting to urinate while inserting a urethral
      catheter to normal catheter insertion.

      Males aged 18 years and older who will be referred for multichannel Urodynamic study in order
      to evaluate lower urinary tract symptoms will be included.

      Patients will be randomized to 2 groups: (1) Patients who will be requested to urinate while
      catheterising the urethra to its full length; (2), Patients who will be requested to lie
      while catheterising the urethra, without further instructions from the medical professional.
      In both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the
      urethra. The randomization technique will be employed by a computerized random number
      generator.

      A 12F Tieman urethral catheter will be introduced in order to measure post-void residual
      volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch
      Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling
      will be carried out using room temperature saline at a filling rate of 50 ml/min.

      Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual
      analog pain scale (VAS) in different time points: before the procedure (baseline),
      immediately after gel instillation, immediately after the introduction of the Tieman
      catheter, 15 minutes after the catheter will be taken out.

      Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the
      study evaluates pain during the procedure the time frame of the study and assessment is very
      short. longer follow-up is not needed.
observational model: Case-Control
time perspective: Prospective
measure: Change from baseline in visual analog pain scales
time frame: Before catheterisation, during catheterisation, 15 minutes after catheterisation
description: A 0 to 10 visual analog pain scale (VAS)
arm group label: Urination, urethral catheterisation
description: Act of urination during urethral catheterisation in males
arm group label: Lie, catheterisation, urethra
description: Urethral catheterisation without medical professional guidance
intervention type: Other
intervention name: Urination during urethral catheterisation
description: Requesting the patient to urinate while inserting urethral catheter
arm group label: Urination, urethral catheterisation
intervention type: Other
intervention name: Urethral catheterisation, without further guidance
description: Lying, inserting urethral catheter, without further guidance from health care professional
arm group label: Lie, catheterisation, urethra
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kobi Stav, MD
role: Principal Investigator
affiliation: Assaf Harofe Medical Center
last name: Kobi Stav, MD
phone: 972-8-9778461
email: stavkobi@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Assaf-Harofeh Medical Center
investigator full name: Assaf Harofeh MC
investigator title: Dr. Kobi Stav