<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/NCT01699425</url>
  </required_header>
  <id_info>
    <org_study_id>AJA201205</org_study_id>
    <nct_id>NCT01699425</nct_id>
  </id_info>
  <brief_title>Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.</brief_title>
  <official_title>Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Viladecans</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Serveis de Salut Integrats Baix Empordà</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <brief_summary>
    <textblock>
      The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates&#xD;
      comparable to those obtained by retropubic suburethral tape, becoming the first line&#xD;
      treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not&#xD;
      exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In&#xD;
      addition it is commonly performed under general or regional anesthesia1-3. The&#xD;
      single-incision mini-slings (SIMS) were developed to reduce the risk of complications by&#xD;
      avoiding the blind passage of the trocars through the obturator space. In addition, the use&#xD;
      of SIMS could enable surgeons to perform the procedure truly under local anesthesia.&#xD;
&#xD;
      Different devices for SIMS procedure are available. However, the evidence about their&#xD;
      efficacy is controversial4-7. The main limitation of these devices could be the predetermined&#xD;
      length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows&#xD;
      adjusting the length of the sling to each individual woman and provides a robust fixation&#xD;
      into the obturator membrane. Recent prospective studies on the efficacy and safety of the&#xD;
      sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use&#xD;
      SIMS in the context of research studies10.&#xD;
&#xD;
      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is&#xD;
      non-inferior to that of a standard TOT, as well as to compare the comorbidity of both&#xD;
      procedures. Owing to the new appearance and fast evolution of these procedures, randomized&#xD;
      comparative studies with SIMS are required in order to determine its place in the treatment&#xD;
      of SUI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.</measure>
    <time_frame>Up to one year</time_frame>
    <description>Percentage of patients who are regarded as cured or improved based on the following criteria:&#xD;
Improvement on the International consultation on Incontinence Urinary Questionnaire-Short Form 1 year after the surgery.&#xD;
Negative Cough Stress test 1 year after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>0, 1, 6 and 12 months after surgery</time_frame>
    <description>Comparison of the intra- and postoperative complications between procedures</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the Maximal Urethral Closure Pressure.</measure>
    <time_frame>One year after surgery.</time_frame>
    <description>Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Female Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Ajust</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group: surgery to treat stress urinary incontinence with the sling Ajust®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classical transobturator tape</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: surgery to treat stress urinary incontinence with the Align® sling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ajust sling</intervention_name>
    <arm_group_label>Ajust</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Classical transobturator sling</intervention_name>
    <description>Control group</description>
    <arm_group_label>Classical transobturator tape</arm_group_label>
    <other_name>Align®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stress urinary incontinence with urethral hypermobility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapacity to understand the information or give their consent.&#xD;
&#xD;
          -  Previous anti-incontinence surgery with slings.&#xD;
&#xD;
          -  Urethral hypomobility (Q-tip test &lt;30º).&#xD;
&#xD;
          -  Low pressure urethra (MUCP &lt; 20cmH2O).&#xD;
&#xD;
          -  Detrusor overactivity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Hospitalet</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Viladecans</name>
      <address>
        <city>Viladecans</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Palamós</name>
      <address>
        <city>Palamós</city>
        <state>Girona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>E-08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress urinary incontinence.</keyword>
  <keyword>Suburethral sling.</keyword>
  <keyword>Single-incision suburethral sling.</keyword>
  <keyword>Ajust.</keyword>
  <keyword>Transobturator tape.</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>
  <!-- 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/NCT01699425
org study id: AJA201205
nct id: NCT01699425
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates
      comparable to those obtained by retropubic suburethral tape, becoming the first line
      treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not
      exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In
      addition it is commonly performed under general or regional anesthesia1-3. The
      single-incision mini-slings (SIMS) were developed to reduce the risk of complications by
      avoiding the blind passage of the trocars through the obturator space. In addition, the use
      of SIMS could enable surgeons to perform the procedure truly under local anesthesia.

      Different devices for SIMS procedure are available. However, the evidence about their
      efficacy is controversial4-7. The main limitation of these devices could be the predetermined
      length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows
      adjusting the length of the sling to each individual woman and provides a robust fixation
      into the obturator membrane. Recent prospective studies on the efficacy and safety of the
      sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use
      SIMS in the context of research studies10.

      The objective of this study is to establish if the effectiveness of the SIMS Ajust® is
      non-inferior to that of a standard TOT, as well as to compare the comorbidity of both
      procedures. Owing to the new appearance and fast evolution of these procedures, randomized
      comparative studies with SIMS are required in order to determine its place in the treatment
      of SUI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes.
time frame: Up to one year
description: Percentage of patients who are regarded as cured or improved based on the following criteria:
Improvement on the International consultation on Incontinence Urinary Questionnaire-Short Form 1 year after the surgery.
Negative Cough Stress test 1 year after surgery.
measure: Number of participants with adverse events
time frame: 0, 1, 6 and 12 months after surgery
description: Comparison of the intra- and postoperative complications between procedures
measure: Change in the Maximal Urethral Closure Pressure.
time frame: One year after surgery.
description: Comparison of the changes in the Maximal Urethral Closure Pressure (cmH2O) measured preoperatively and 1 year after surgery.
arm group label: Ajust
arm group type: Experimental
description: Experimental group: surgery to treat stress urinary incontinence with the sling Ajust®
arm group label: Classical transobturator tape
arm group type: Active Comparator
description: Control group: surgery to treat stress urinary incontinence with the Align® sling.
intervention type: Device
intervention name: Ajust sling
arm group label: Ajust
intervention type: Device
intervention name: Classical transobturator sling
description: Control group
arm group label: Classical transobturator tape
other name: Align®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress