<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/NCT04500860</url>
  </required_header>
  <id_info>
    <org_study_id>Cairo University</org_study_id>
    <nct_id>NCT04500860</nct_id>
  </id_info>
  <brief_title>Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.</brief_title>
  <official_title>Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      90 female patients with overactive bladder syndrome divided into 3 groups group A subjected&#xD;
      to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo.&#xD;
      They are evaluated as using OAB symptoms score for 6 months follow up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of efficacy of tadalafil 5 mg</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Group A Tadalafil 5 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients subjected to Daily dose of tadalafil 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B Tolterodine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients subjected to tolterodine 4 mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 patients subjected to placebo daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose tadalafil 5 mg</intervention_name>
    <description>Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence</description>
    <arm_group_label>Group A Tadalafil 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolterodine 4 Mg Oral Capsule, Extended Release</intervention_name>
    <description>To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder</description>
    <arm_group_label>Group B Tolterodine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo drugs</description>
    <arm_group_label>Group C placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any female with overactive bladder syndrome, urgency with or without urgency urinary&#xD;
             incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Urinary tract infection&#xD;
&#xD;
          -  neurologic abnormality&#xD;
&#xD;
          -  Pure Stress urinary incontinence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samer Morsy</name>
      <address>
        <city>Cairo</city>
        <zip>12334</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Samer Morsy</investigator_full_name>
    <investigator_title>Urology lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</mesh_term>
    <mesh_term>Tolterodine Tartrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04500860
org study id: Cairo University
nct id: NCT04500860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome
90 female patients with overactive bladder syndrome divided into 3 groups group A subjected
      to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo.
      They are evaluated as using OAB symptoms score for 6 months follow up
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up
time frame: 6 months
description: Evaluation of efficacy of tadalafil 5 mg
arm group label: Group A Tadalafil 5 mg
arm group type: Active Comparator
description: 30 patients subjected to Daily dose of tadalafil 5mg
arm group label: Group B Tolterodine
arm group type: Active Comparator
description: 30 patients subjected to tolterodine 4 mg daily
arm group label: Group C placebo
arm group type: Placebo Comparator
description: 30 patients subjected to placebo daily
intervention type: Drug
intervention name: Low dose tadalafil 5 mg
description: Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence
arm group label: Group A Tadalafil 5 mg
intervention type: Drug
intervention name: Tolterodine 4 Mg Oral Capsule, Extended Release
description: To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder
arm group label: Group B Tolterodine
intervention type: Drug
intervention name: Placebo
description: Placebo drugs
arm group label: Group C placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Samer Morsy
investigator title: Urology lecturer
mesh term: Urinary Incontinence
mesh term: Urinary Bladder, Overactive
mesh term: Syndrome
mesh term: Tadalafil
mesh term: Tolterodine Tartrate
sharing ipd: Undecided