xml: <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/NCT06012370</url>
    </required_header>
    <id_info>
      <org_study_id>HBH-1572023</org_study_id>
      <nct_id>NCT06012370</nct_id>
    </id_info>
    <brief_title>Injecting Plasma-rich Platelets &amp; Hyaluronic Acid for Patients With Stress Urinary Incontinence</brief_title>
    <official_title>A Pilot Study of Injecting Plasma-rich Platelets and Hyaluronic Acid for Patients With Stress INCONTINENCE; A NON-RANDOMIZED CLINICAL TRIAL</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>
        Injection of PRP and hyaluronic acid in stress incontinence patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Operative details Dissection of the ant vag wall from the urethra and lower part of the&#xD;
        bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined&#xD;
        with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck)&#xD;
        then closure of the vag wall ( after removal of the excess vag tissue.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>Stress incontinence change</measure>
      <time_frame>6 months</time_frame>
      <description>Visual Assessment System assessment</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Stress Incontinence, Female</condition>
    <arm_group>
      <arm_group_label>Stress incontinence patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>PRP injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PRP injection</intervention_name>
      <description>Injection of PRP and hyaluronic acid</description>
      <arm_group_label>Stress incontinence patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  stress incontinence patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  prolapse patients&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
      <investigator_full_name>suzy abdelaziz Abdelhamid</investigator_full_name>
      <investigator_title>Assistant professor doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Incontinence, Stress</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012370
  org study id: HBH-1572023
  nct id: NCT06012370
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Injection of PRP and hyaluronic acid in stress incontinence patients
  Operative details Dissection of the ant vag wall from the urethra and lower part of the
        bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined
        with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck)
        then closure of the vag wall ( after removal of the excess vag tissue.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Stress incontinence change
  time frame: 6 months
  description: Visual Assessment System assessment
  arm group label: Stress incontinence patients
  arm group type: Other
  description: PRP injection
  intervention type: Procedure
  intervention name: PRP injection
  description: Injection of PRP and hyaluronic acid
  arm group label: Stress incontinence patients
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Kasr El Aini Hospital
  investigator full name: suzy abdelaziz Abdelhamid
  investigator title: Assistant professor doctor
  mesh term: Urinary Incontinence, Stress