<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/NCT03280420</url>
  </required_header>
  <id_info>
    <org_study_id>123urology</org_study_id>
    <nct_id>NCT03280420</nct_id>
  </id_info>
  <brief_title>Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment</brief_title>
  <official_title>Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salem Hassan Salem Mohamed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</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>
      The aim of this work is to compare between early (3days) and late(7days) removal of urinary&#xD;
      catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under&#xD;
      Tamsulosin treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized study, Men with acute urinary retention secondary to benign&#xD;
      prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were&#xD;
      randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days,&#xD;
      After that the catheter was removed and the ability to void unaided assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2017</start_date>
  <completion_date type="Actual">September 16, 2017</completion_date>
  <primary_completion_date type="Actual">September 16, 2017</primary_completion_date>
  <phase>N/A</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>All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The duration for trial without catheter</measure>
    <time_frame>6 Months</time_frame>
    <description>To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factor affecting trial without catheter</measure>
    <time_frame>6 Months</time_frame>
    <description>To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>BPH With Urinary Obstruction</condition>
  <arm_group>
    <arm_group_label>early catheter removal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>late catheter removal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early catheter removal</intervention_name>
    <description>Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days.&#xD;
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.</description>
    <arm_group_label>early catheter removal</arm_group_label>
    <other_name>After 3 days catheter removal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Late catheter removal</intervention_name>
    <description>Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days.&#xD;
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.</description>
    <arm_group_label>late catheter removal</arm_group_label>
    <other_name>After 7 days catheter removal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having first attack of acute urinary retention secondary to BPH.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal impairment.&#xD;
&#xD;
          -  Suspected urethral stricture.&#xD;
&#xD;
          -  Neurogenic bladder.&#xD;
&#xD;
          -  Cancer prostate.&#xD;
&#xD;
          -  Medically induced retention.&#xD;
&#xD;
          -  Previous use of alpha blockers.&#xD;
&#xD;
          -  History of drug hypersensitivity or allergy to Tamsulosin.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed M Badr, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed F El Saeed El Ebiary, MD</last_name>
    <role>Study Director</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine ,Al Azhar university</name>
      <address>
        <city>Cairo</city>
        <state>El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Salem Hassan Salem Mohamed</investigator_full_name>
    <investigator_title>Cairo, Egypt</investigator_title>
  </responsible_party>
  <keyword>Acute urinary retention</keyword>
  <keyword>BPH</keyword>
  <keyword>TWOC</keyword>
  <keyword>Tamsulosin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03280420/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>September 26, 2017</submitted>
    <returned>October 24, 2017</returned>
    <submitted>October 29, 2017</submitted>
    <returned>August 3, 2018</returned>
  </pending_results>
  <!-- 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/NCT03280420
org study id: 123urology
nct id: NCT03280420
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to compare between early (3days) and late(7days) removal of urinary
      catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under
      Tamsulosin treatment.
This is a prospective randomized study, Men with acute urinary retention secondary to benign
      prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were
      randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days,
      After that the catheter was removed and the ability to void unaided assessed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.
primary purpose: Treatment
masking: None (Open Label)
measure: The duration for trial without catheter
time frame: 6 Months
description: To determine the optimum period to remove catheter in patients complaining of acute urinary retention with benign prostatic hyperplasia.
measure: Factor affecting trial without catheter
time frame: 6 Months
description: To evaluate the role of the following in trial without catheter patient's age prostate size residual urine volume prostatic specific antigen (PSA)
arm group label: early catheter removal
arm group type: Active Comparator
description: 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 3 days.
arm group label: late catheter removal
arm group type: Active Comparator
description: 30 patients will receive Tamsulosin hydrochloride 0.4 mg once daily and the catheter will be removed after 7 days.
intervention type: Procedure
intervention name: Early catheter removal
description: Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days.
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.
arm group label: early catheter removal
other name: After 3 days catheter removal
intervention type: Procedure
intervention name: Late catheter removal
description: Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days.
After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy.
arm group label: late catheter removal
other name: After 7 days catheter removal
criteria: 
gender: Male
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed M Badr, PHD
role: Study Chair
affiliation: Al-Azhar University
last name: Mohamed F El Saeed El Ebiary, MD
role: Study Director
affiliation: Al-Azhar University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Al-Azhar University
investigator full name: Salem Hassan Salem Mohamed
investigator title: Cairo, Egypt
mesh term: Urinary Retention
sharing ipd: No
provided document: 
submitted: September 26, 2017
returned: October 24, 2017
submitted: October 29, 2017
returned: August 3, 2018