<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/NCT03236922</url>
  </required_header>
  <id_info>
    <org_study_id>H-38672</org_study_id>
    <nct_id>NCT03236922</nct_id>
  </id_info>
  <brief_title>Autologous Slings With Vesico-Vaginal Fistula Repair</brief_title>
  <official_title>Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is clear from multiple accounts in the literature that patients with a vesico-vaginal&#xD;
      fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of&#xD;
      residual incontinence. Performing subsequent surgeries after the initial VVF repair risks&#xD;
      additional complications. Therefore, placement of an autologous sling at the time of initial&#xD;
      VVF repair would not only assist in covering the fistula, but would also imitate the&#xD;
      physiologic support that would theoretically improve urethral function. A rectus fascia sling&#xD;
      would most naturally provide this support and warrants testing against the success of the PC&#xD;
      sling.&#xD;
&#xD;
      Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the&#xD;
      urethra. Therefore, this group of patients is the target population for this study. As there&#xD;
      is currently no standard of care for repairing large urethral defects, this procedural&#xD;
      technique combined with otherwise standardized fistula repair would not introduce any&#xD;
      foreseeable harm to patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Long-term Continence Status</measure>
    <time_frame>Six months after surgery</time_frame>
    <description>Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vesico-vaginal fistula repaired</measure>
    <time_frame>One month after surgery</time_frame>
    <description>To ensure the VVF is still closed and was not compromised due to the sling</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Vesicovaginal Fistula</condition>
  <arm_group>
    <arm_group_label>Pubococcygeus Sling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is one anti-incontinence technique commonly used at the time of fistula surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rectus Fascia Sling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pubococcygeus sling</intervention_name>
    <description>The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.</description>
    <arm_group_label>Pubococcygeus Sling</arm_group_label>
    <other_name>pubococcygeal sling</other_name>
    <other_name>pubococcygeus graft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rectus fascia sling</intervention_name>
    <description>Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.</description>
    <arm_group_label>Rectus Fascia Sling</arm_group_label>
    <other_name>rectus fascia graft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery&#xD;
&#xD;
          -  Patients who have consented for an autologous sling&#xD;
&#xD;
          -  Patients who have not previously undergone repair attempt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who require an abdominal approach to the VVF repair&#xD;
&#xD;
          -  Patients found at surgery not to have a Goh 3 or 4 class VVF&#xD;
&#xD;
          -  Patients requiring a complete urethral reconstruction&#xD;
&#xD;
          -  Patients who have undergone previous attempt at repair&#xD;
&#xD;
          -  Patients who require an alternative tissue grafting other than the rectus fascia or&#xD;
             pubbococcygeus decided by the surgeon at the time of surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Pope, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fistula Care Center</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <reference>
    <citation>Ascher-Walsh CJ, Capes TL, Lo Y, Idrissa A, Wilkinson J, Echols K, Crawford B, Genadry R. Sling procedures after repair of obstetric vesicovaginal fistula in Niamey, Niger. Int Urogynecol J. 2010 Nov;21(11):1385-90. doi: 10.1007/s00192-010-1202-5. Epub 2010 Jun 17.</citation>
    <PMID>20556597</PMID>
  </reference>
  <results_reference>
    <citation>Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG. 2006 Apr;113(4):482-5. doi: 10.1111/j.1471-0528.2006.00875.x. Epub 2006 Feb 20.</citation>
    <PMID>16489933</PMID>
  </results_reference>
  <results_reference>
    <citation>Browning A. Prevention of residual urinary incontinence following successful repair of obstetric vesico-vaginal fistula using a fibro-muscular sling. BJOG. 2004 Apr;111(4):357-61. doi: 10.1111/j.1471-0528.2004.00080.x.</citation>
    <PMID>15008773</PMID>
  </results_reference>
  <results_reference>
    <citation>Carey MP, Goh JT, Fynes MM, Murray CJ. Stress urinary incontinence after delayed primary closure of genitourinary fistula: a technique for surgical management. Am J Obstet Gynecol. 2002 May;186(5):948-53. doi: 10.1067/mob.2002.122247.</citation>
    <PMID>12015520</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 21, 2016</study_first_submitted>
  <study_first_submitted_qc>July 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 29, 2017</last_update_submitted>
  <last_update_submitted_qc>July 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Jeffrey Wilkinson</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>obstetric fistula, anti-incontinence techniques</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginal Fistula</mesh_term>
    <mesh_term>Vesicovaginal Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>No.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 6, 2020</submitted>
    <returned>March 18, 2020</returned>
  </pending_results>
  <!-- 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/NCT03236922
org study id: H-38672
nct id: NCT03236922
lead sponsor: 
has dmc: Yes
It is clear from multiple accounts in the literature that patients with a vesico-vaginal
      fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of
      residual incontinence. Performing subsequent surgeries after the initial VVF repair risks
      additional complications. Therefore, placement of an autologous sling at the time of initial
      VVF repair would not only assist in covering the fistula, but would also imitate the
      physiologic support that would theoretically improve urethral function. A rectus fascia sling
      would most naturally provide this support and warrants testing against the success of the PC
      sling.

      Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the
      urethra. Therefore, this group of patients is the target population for this study. As there
      is currently no standard of care for repairing large urethral defects, this procedural
      technique combined with otherwise standardized fistula repair would not introduce any
      foreseeable harm to patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Long-term Continence Status
time frame: Six months after surgery
description: Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed.
measure: Vesico-vaginal fistula repaired
time frame: One month after surgery
description: To ensure the VVF is still closed and was not compromised due to the sling
arm group label: Pubococcygeus Sling
arm group type: Active Comparator
description: This is one anti-incontinence technique commonly used at the time of fistula surgery.
arm group label: Rectus Fascia Sling
arm group type: Active Comparator
description: This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
intervention type: Procedure
intervention name: Pubococcygeus sling
description: The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
arm group label: Pubococcygeus Sling
other name: pubococcygeal sling
other name: pubococcygeus graft
intervention type: Procedure
intervention name: Rectus fascia sling
description: Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
arm group label: Rectus Fascia Sling
other name: rectus fascia graft
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Pope, MD, MPH
role: Study Director
affiliation: Baylor College of Medicine
facility: 
country: Malawi
citation: Ascher-Walsh CJ, Capes TL, Lo Y, Idrissa A, Wilkinson J, Echols K, Crawford B, Genadry R. Sling procedures after repair of obstetric vesicovaginal fistula in Niamey, Niger. Int Urogynecol J. 2010 Nov;21(11):1385-90. doi: 10.1007/s00192-010-1202-5. Epub 2010 Jun 17.
PMID: 20556597
citation: Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG. 2006 Apr;113(4):482-5. doi: 10.1111/j.1471-0528.2006.00875.x. Epub 2006 Feb 20.
PMID: 16489933
citation: Browning A. Prevention of residual urinary incontinence following successful repair of obstetric vesico-vaginal fistula using a fibro-muscular sling. BJOG. 2004 Apr;111(4):357-61. doi: 10.1111/j.1471-0528.2004.00080.x.
PMID: 15008773
citation: Carey MP, Goh JT, Fynes MM, Murray CJ. Stress urinary incontinence after delayed primary closure of genitourinary fistula: a technique for surgical management. Am J Obstet Gynecol. 2002 May;186(5):948-53. doi: 10.1067/mob.2002.122247.
PMID: 12015520
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Jeffrey Wilkinson
investigator title: Professor of Obstetrics and Gynecology
mesh term: Vaginal Fistula
mesh term: Vesicovaginal Fistula
mesh term: Fistula
sharing ipd: Yes
ipd description: No.
submitted: March 6, 2020
returned: March 18, 2020