<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/NCT02263534</url>
  </required_header>
  <id_info>
    <org_study_id>SIMS001</org_study_id>
    <nct_id>NCT02263534</nct_id>
  </id_info>
  <brief_title>Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence</brief_title>
  <official_title>Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on previous studies the single incision minisling is an easy less invasive procedure&#xD;
      with fewer complications and cure rate similar to conventional midurethral slings in the&#xD;
      treatment of female stress urinary incontinence. The aim of this study is to test the&#xD;
      hypothesis that the single incision mini-sling placed in the &quot;U&quot; position is not inferior to&#xD;
      TVT in this patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective cure rate of urinary incontinence at 12 months after surgery</measure>
    <time_frame>12 months</time_frame>
    <description>Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>subjective cure rate of urinary incontinence at 12 months after surgery</measure>
    <time_frame>12 months</time_frame>
    <description>subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with short- term complications</measure>
    <time_frame>12 months</time_frame>
    <description>short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with long-term complications</measure>
    <time_frame>12 months</time_frame>
    <description>long-term complications: erosion, dyspareunia and recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>minisling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this arm will undergo single incision minisling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tension free vaginal tape</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients in this arm will undergo tension free vaginal tape</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>single incision minisling</intervention_name>
    <description>midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed</description>
    <arm_group_label>minisling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tension free vaginal tape</intervention_name>
    <description>midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed</description>
    <arm_group_label>tension free vaginal tape</arm_group_label>
    <other_name>TVT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with urodynamic stress urinary incontinence, with or without pelvic organ&#xD;
             prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with overactive bladder on urodynamic study.&#xD;
&#xD;
          -  Patients with voiding dysfunction.&#xD;
&#xD;
          -  Patients with intrinsic sphincteric deficiency.&#xD;
&#xD;
          -  Patients with previous anti-incontinence surgery.&#xD;
&#xD;
          -  Patients on anti-coagulant therapy.&#xD;
&#xD;
          -  Immune-compromised patients (DM, patients on corticosteroids treatment).&#xD;
&#xD;
          -  Refusal of surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ahmed reda, M.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University, Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Reda</investigator_full_name>
    <investigator_title>specialist obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>stress urinary incontinence</keyword>
  <keyword>tension free vaginal tape</keyword>
  <keyword>single incision minisling</keyword>
  <keyword>midurethral sling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_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/NCT02263534
org study id: SIMS001
nct id: NCT02263534
lead sponsor: 
has dmc: No
Based on previous studies the single incision minisling is an easy less invasive procedure
      with fewer complications and cure rate similar to conventional midurethral slings in the
      treatment of female stress urinary incontinence. The aim of this study is to test the
      hypothesis that the single incision mini-sling placed in the "U" position is not inferior to
      TVT in this patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: objective cure rate of urinary incontinence at 12 months after surgery
time frame: 12 months
description: Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
measure: subjective cure rate of urinary incontinence at 12 months after surgery
time frame: 12 months
description: subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
measure: Number of participants with short- term complications
time frame: 12 months
description: short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis
measure: Number of participants with long-term complications
time frame: 12 months
description: long-term complications: erosion, dyspareunia and recurrence
arm group label: minisling
arm group type: Experimental
description: patients in this arm will undergo single incision minisling
arm group label: tension free vaginal tape
arm group type: Sham Comparator
description: patients in this arm will undergo tension free vaginal tape
intervention type: Procedure
intervention name: single incision minisling
description: midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed
arm group label: minisling
intervention type: Procedure
intervention name: tension free vaginal tape
description: midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed
arm group label: tension free vaginal tape
other name: TVT
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ahmed reda, M.Sc
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Reda
investigator title: specialist obstetrics and gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided