<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/NCT04465578</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0001</org_study_id>
    <nct_id>NCT04465578</nct_id>
  </id_info>
  <brief_title>Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.</brief_title>
  <official_title>Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      The aim of this study is to evaluate the incidence of short-term urinary retention and the&#xD;
      cure rate in patients with stress urinary incontinence undergoing surgical treatment with&#xD;
      fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment&#xD;
      technique (&quot;2 fingers&quot;) and measuring the distance between the fixation knot and the&#xD;
      aponeurosis of 4 cm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized double-blind clinical trial will be conducted in women over 18 years of age with&#xD;
      stress urinary incontinence and indication for surgical treatment, who have not undergone&#xD;
      previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of&#xD;
      urinary retention and the rate of cure after the procedure will be evaluated. The incidence&#xD;
      of urinary retention in 1 month postoperatively will be evaluated in the two different&#xD;
      techniques (post-voiding residue &gt; 200ml or the need for intermittent bladder&#xD;
      catheterization) and the cure rate for urinary incontinence (cough test and response &quot;No&quot; to&#xD;
      the question 3 of the Urogenital Distress Inventory questionnaire).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 10, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling</measure>
    <time_frame>1 month</time_frame>
    <description>Urinary retention will be considered the need for bladder catheterization or post-voiding residue&gt; 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.</measure>
    <time_frame>1 month</time_frame>
    <description>Cure will be considered the answer &quot;NO&quot; to the 3rd question of Urogenital Distress Inventory and a negative cough test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Urinary Retention Postoperative</condition>
  <condition>Urinary Retention After Procedure</condition>
  <arm_group>
    <arm_group_label>Sling tension adjustment by classic technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sling tension adjustment by height of 4 cm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sling tension adjustment by classic technique</intervention_name>
    <description>We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)</description>
    <arm_group_label>Sling tension adjustment by classic technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sling tension adjustment by height of 4 cm</intervention_name>
    <description>We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm</description>
    <arm_group_label>Sling tension adjustment by height of 4 cm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and no improvement with conservative management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior anti incontinence surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tiago Rosito, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aline Silva, MD</last_name>
    <phone>+5551991911801</phone>
    <email>aline.urologia@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aline Silva, MD</last_name>
      <phone>+555133598286</phone>
      <email>aline.urologia@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress urinary incontinence</keyword>
  <keyword>Pubovaginal sling</keyword>
  <keyword>Urinary retention</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>
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04465578
org study id: 2020-0001
nct id: NCT04465578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the incidence of short-term urinary retention and the
      cure rate in patients with stress urinary incontinence undergoing surgical treatment with
      fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment
      technique ("2 fingers") and measuring the distance between the fixation knot and the
      aponeurosis of 4 cm.
A randomized double-blind clinical trial will be conducted in women over 18 years of age with
      stress urinary incontinence and indication for surgical treatment, who have not undergone
      previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of
      urinary retention and the rate of cure after the procedure will be evaluated. The incidence
      of urinary retention in 1 month postoperatively will be evaluated in the two different
      techniques (post-voiding residue > 200ml or the need for intermittent bladder
      catheterization) and the cure rate for urinary incontinence (cough test and response "No" to
      the question 3 of the Urogenital Distress Inventory questionnaire).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
time frame: 1 month
description: Urinary retention will be considered the need for bladder catheterization or post-voiding residue> 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.
measure: To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.
time frame: 1 month
description: Cure will be considered the answer "NO" to the 3rd question of Urogenital Distress Inventory and a negative cough test.
arm group label: Sling tension adjustment by classic technique
arm group type: Active Comparator
description: We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
arm group label: Sling tension adjustment by height of 4 cm
arm group type: Active Comparator
description: We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
intervention type: Procedure
intervention name: Sling tension adjustment by classic technique
description: We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
arm group label: Sling tension adjustment by classic technique
intervention type: Procedure
intervention name: Sling tension adjustment by height of 4 cm
description: We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
arm group label: Sling tension adjustment by height of 4 cm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tiago Rosito, Doctor
role: Principal Investigator
affiliation: Hospital de Clinicas de Porto Alegre
last name: Aline Silva, MD
phone: +5551991911801
email: aline.urologia@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Urinary Retention
sharing ipd: No