<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/NCT04480671</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19110286</org_study_id>
    <nct_id>NCT04480671</nct_id>
  </id_info>
  <brief_title>Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy</brief_title>
  <acronym>MERIT</acronym>
  <official_title>Impact of Level III Support Procedure on Normalization of Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled surgical trial evaluating the use of a concomitant posterior&#xD;
      colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to&#xD;
      narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The&#xD;
      study's primary outcome is the proportion of women at 6 months postoperatively who still have&#xD;
      an enlarged genital hiatus.&#xD;
&#xD;
      An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal&#xD;
      area as compared with the genital hiatus by using preoperative and postoperative&#xD;
      transperineal ultrasounds. Subjects will be invited to participate, but is not required for&#xD;
      study participation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Actual">February 2, 2023</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>
    <masking_description>Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Enlarged Genital Hiatus at 6 months postoperatively</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>Proportion of subjects with enlarged genital hiatus on pelvic exam</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite prolapse recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective prolapse recurrence</measure>
    <time_frame>24 months</time_frame>
    <description>Any symptomatic recurrence of prolapse on questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspareunia postoperatively</measure>
    <time_frame>6, 12 months postoperatively</time_frame>
    <description>Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].This questionnaire indicates worse pain with sex with higher score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Function postoperatively</measure>
    <time_frame>6, 12 months postoperatively</time_frame>
    <description>Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic Floor Distress Inventory Change</measure>
    <time_frame>baseline, 6, 12 months postoperatively</time_frame>
    <description>Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levator Hiatal Area</measure>
    <time_frame>baseline, 6 months postoperatively</time_frame>
    <description>Measurement of the levator hiatus on transperineal ultrasound</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Sacrocolpopexy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sacrocolpopexy and concomitant level III support procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Level III support procedure</intervention_name>
    <description>A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.</description>
    <arm_group_label>Sacrocolpopexy and concomitant level III support procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally Invasive Sacrocolpopexy</intervention_name>
    <description>All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.</description>
    <arm_group_label>Sacrocolpopexy</arm_group_label>
    <arm_group_label>Sacrocolpopexy and concomitant level III support procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transperineal ultrasound of the Pelvic Floor</intervention_name>
    <description>Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.</description>
    <arm_group_label>Sacrocolpopexy</arm_group_label>
    <arm_group_label>Sacrocolpopexy and concomitant level III support procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects with pelvic organ prolapse (POP)&#xD;
&#xD;
          -  Planning a surgical repair of POP with minimally invasive sacrocolpopexy&#xD;
&#xD;
          -  Preoperative resting genital hiatus measure between 4.0 and 7.5cm&#xD;
&#xD;
        Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office&#xD;
        exams or if they do not otherwise meet inclusion criteria above&#xD;
&#xD;
        *Note: we will NOT exclude patients based on prior surgical history (including prior&#xD;
        posterior colporrhaphy)*&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6.</citation>
    <PMID>29425837</PMID>
  </reference>
  <reference>
    <citation>Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036.</citation>
    <PMID>24368486</PMID>
  </reference>
  <reference>
    <citation>Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.</citation>
    <PMID>22397900</PMID>
  </reference>
  <reference>
    <citation>Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. doi: 10.1111/j.1471-0528.1997.tb10654.x.</citation>
    <PMID>8988702</PMID>
  </reference>
  <reference>
    <citation>Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593.</citation>
    <PMID>29742664</PMID>
  </reference>
  <reference>
    <citation>Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528.</citation>
    <PMID>29210807</PMID>
  </reference>
  <reference>
    <citation>Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.</citation>
    <PMID>31449806</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 17, 2019</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Stephanie Glass Clark</investigator_full_name>
    <investigator_title>Fellow, Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make IPD available to other researchers</ipd_description>
  </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/NCT04480671
org study id: STUDY19110286
nct id: NCT04480671
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior
      colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to
      narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The
      study's primary outcome is the proportion of women at 6 months postoperatively who still have
      an enlarged genital hiatus.

      An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal
      area as compared with the genital hiatus by using preoperative and postoperative
      transperineal ultrasounds. Subjects will be invited to participate, but is not required for
      study participation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.
measure: Enlarged Genital Hiatus at 6 months postoperatively
time frame: 6 months postoperatively
description: Proportion of subjects with enlarged genital hiatus on pelvic exam
measure: Composite prolapse recurrence
time frame: 12 months
description: Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.
measure: Subjective prolapse recurrence
time frame: 24 months
description: Any symptomatic recurrence of prolapse on questionnaire
measure: Dyspareunia postoperatively
time frame: 6, 12 months postoperatively
description: Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].This questionnaire indicates worse pain with sex with higher score.
measure: Sexual Function postoperatively
time frame: 6, 12 months postoperatively
description: Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity.
measure: Pelvic Floor Distress Inventory Change
time frame: baseline, 6, 12 months postoperatively
description: Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life.
measure: Levator Hiatal Area
time frame: baseline, 6 months postoperatively
description: Measurement of the levator hiatus on transperineal ultrasound
arm group label: Sacrocolpopexy
arm group type: Other
description: This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.
arm group label: Sacrocolpopexy and concomitant level III support procedure
arm group type: Active Comparator
description: This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.
intervention type: Procedure
intervention name: Level III support procedure
description: A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.
arm group label: Sacrocolpopexy and concomitant level III support procedure
intervention type: Procedure
intervention name: Minimally Invasive Sacrocolpopexy
description: All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
arm group label: Sacrocolpopexy
arm group label: Sacrocolpopexy and concomitant level III support procedure
intervention type: Other
intervention name: Transperineal ultrasound of the Pelvic Floor
description: Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.
arm group label: Sacrocolpopexy
arm group label: Sacrocolpopexy and concomitant level III support procedure
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6.
PMID: 29425837
citation: Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036.
PMID: 24368486
citation: Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.
PMID: 22397900
citation: Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. doi: 10.1111/j.1471-0528.1997.tb10654.x.
PMID: 8988702
citation: Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593.
PMID: 29742664
citation: Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528.
PMID: 29210807
citation: Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.
PMID: 31449806
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Stephanie Glass Clark
investigator title: Fellow, Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, Principal Investigator
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No
ipd description: There is no plan to make IPD available to other researchers