<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/NCT01705444</url>
  </required_header>
  <id_info>
    <org_study_id>E-11-541</org_study_id>
    <secondary_id>E-11-541</secondary_id>
    <nct_id>NCT01705444</nct_id>
  </id_info>
  <brief_title>The Spanner Prostatic Stent and Patient's Quality of Life</brief_title>
  <acronym>SpannerQoL</acronym>
  <official_title>The Impact of the Temporary Stent on Parameters of Voiding Function and on the Quality of Life Among Patients With LUTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Princess Al-Johara Al-Ibrahim Cancer Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Princess Al-Johara Al-Ibrahim Cancer Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute urinary retention is considered one of the most common problems in the older age,&#xD;
      especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary&#xD;
      retention using the Foley catheter still causes problems at the level of patient movement and&#xD;
      the daily exercises. However, with the emergence of a new device, the spanner, investigators&#xD;
      believe that many of the above mentioned problems can be resolved. This tool may provide more&#xD;
      freedom for the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research comes up to date with technological innovations in the field of health where&#xD;
      investigators want to evaluate the efficacy of a new catheter (The Spanner) to reduce the&#xD;
      acute urinary retention and to determine whether they are consistent with the daily life of&#xD;
      the patient, compared to the Foley catheter previously used.&#xD;
&#xD;
      The study include all patients with acute urinary retention due to prostatic obstruction.&#xD;
      Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral&#xD;
      or bladder surgery, or if they were at high risk of developing bladder or kidney stones The&#xD;
      study will be national community based study conducted in different hospitals in Saudi&#xD;
      Arabia. Investigators will test two different types of stents in patients with acute urinary&#xD;
      retention for a short period (not exceeding five days), find out the compatibility of these&#xD;
      stents with the daily life of the patient and determine their impact on his quality of life&#xD;
      using an appropriate questionnaire after each use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life questionnaire after using the Foley catheter</measure>
    <time_frame>After five days</time_frame>
    <description>Using a validated Quality of life questionnaire designed for the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire after using the spanner</measure>
    <time_frame>After five days</time_frame>
    <description>Using the same Quality of life questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>IPSS international prostate symptom score assessment</measure>
    <time_frame>After five days of using the Spanner</time_frame>
    <description>Assessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Prostatic Obstruction</condition>
  <arm_group>
    <arm_group_label>Foley catheter and The Spanner Insertion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Quality of life questionnaire after using the Foley catheter and the Spanner</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley Catheter and The Spanner Insertion</intervention_name>
    <description>A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.</description>
    <arm_group_label>Foley catheter and The Spanner Insertion</arm_group_label>
    <other_name>Foley Catheter</other_name>
    <other_name>The Spanner</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Urinary retention due to Prostatic Obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects were excluded if they had prior surgery for prostate cancer, had any other&#xD;
             urethral or bladder surgery, or if they were at high risk of developing bladder or&#xD;
             kidney stones&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danny M. Rabah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Al-Johara Al-Ibrahim Cancer Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Al-Johara Cancer Research Center, Riyadh, Saudi Arabia</name>
      <address>
        <city>Riyadh</city>
        <state>Ar Riyad</state>
        <zip>11541</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary retention</keyword>
  <keyword>Foley catheter</keyword>
  <keyword>The Spanner</keyword>
  <keyword>Quality of life</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results will be published in per-reviewed journal</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/NCT01705444
org study id: E-11-541
secondary id: E-11-541
nct id: NCT01705444
lead sponsor: 
has dmc: Yes
Acute urinary retention is considered one of the most common problems in the older age,
      especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary
      retention using the Foley catheter still causes problems at the level of patient movement and
      the daily exercises. However, with the emergence of a new device, the spanner, investigators
      believe that many of the above mentioned problems can be resolved. This tool may provide more
      freedom for the patient.
This research comes up to date with technological innovations in the field of health where
      investigators want to evaluate the efficacy of a new catheter (The Spanner) to reduce the
      acute urinary retention and to determine whether they are consistent with the daily life of
      the patient, compared to the Foley catheter previously used.

      The study include all patients with acute urinary retention due to prostatic obstruction.
      Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral
      or bladder surgery, or if they were at high risk of developing bladder or kidney stones The
      study will be national community based study conducted in different hospitals in Saudi
      Arabia. Investigators will test two different types of stents in patients with acute urinary
      retention for a short period (not exceeding five days), find out the compatibility of these
      stents with the daily life of the patient and determine their impact on his quality of life
      using an appropriate questionnaire after each use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life questionnaire after using the Foley catheter
time frame: After five days
description: Using a validated Quality of life questionnaire designed for the study
measure: Quality of life questionnaire after using the spanner
time frame: After five days
description: Using the same Quality of life questionnaire
measure: IPSS international prostate symptom score assessment
time frame: After five days of using the Spanner
description: Assessment of the prostate symptom score using the IPSS questionnaire five days after using the Spanner
arm group label: Foley catheter and The Spanner Insertion
arm group type: Other
description: Quality of life questionnaire after using the Foley catheter and the Spanner
intervention type: Device
intervention name: Foley Catheter and The Spanner Insertion
description: A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.
arm group label: Foley catheter and The Spanner Insertion
other name: Foley Catheter
other name: The Spanner
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Danny M. Rabah, MD
role: Principal Investigator
affiliation: Princess Al-Johara Al-Ibrahim Cancer Research Center
facility: 
country: Saudi Arabia
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Results will be published in per-reviewed journal