<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/NCT03841513</url>
  </required_header>
  <id_info>
    <org_study_id>STU00208016</org_study_id>
    <nct_id>NCT03841513</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence</brief_title>
  <acronym>MICRO</acronym>
  <official_title>Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Friends of Prentice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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>
      This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the&#xD;
      time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the&#xD;
      participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and&#xD;
      half of the participants will undergo sacrocolpopexy alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the United States it is estimated that 13% of women will undergo surgery for POP by age&#xD;
      80. In patients without symptoms of stress urinary incontinence (SUI), surgical correction of&#xD;
      pelvic organ prolapse (POP) by itself can result in postoperative occult SUI. Two multicenter&#xD;
      randomized trials of stress-continent women undergoing vaginal or open prolapse surgery&#xD;
      showed lower rates of postoperative SUI if patients undergo concomitant anti-incontinence&#xD;
      procedures. However, adverse outcomes vary based on the type of anti-incontinence procedure&#xD;
      (open Burch colposuspension or retropubic midurethral sling) and route of surgery (open or&#xD;
      vaginal), and therefore the preferred approach to address occult SUI is unknown.&#xD;
&#xD;
      Sacrocolpopexy is the gold standard surgical repair of pelvic organ prolapse of the apical&#xD;
      compartment. The Burch colposuspension is a retropubic procedure in which the periurethral&#xD;
      tissue of the anterior vagina is affixed to Cooper's ligament on either side using permanent&#xD;
      suture bridges. In the Colpopexy and Urinary Reduction Efforts (CARE) trial patients without&#xD;
      preoperative symptoms of SUI were randomized to receive or not to receive concomitant&#xD;
      prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy. At three months,&#xD;
      the subjects who underwent the Burch procedure were found to have lower rates of SUI after&#xD;
      surgery (33.6%) compared to the control group (57.4%). Furthermore, of patients who tested&#xD;
      negative for SUI on preoperative urodynamic testing, 22.9 % of those who underwent the Burch&#xD;
      procedure had SUI compared to 47.9% in the control group. Burch colposuspension did not&#xD;
      increase the rate of urinary retention, urge incontinence, urinary urgency, urinary tract&#xD;
      infection, intra or post-operative complications. The data in this trial supported the&#xD;
      placement of prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy.&#xD;
&#xD;
      Over the last decade, there has been a shift away from open routes of surgical access&#xD;
      secondary to decreased morbidity and quicker recovery associated with minimally invasive&#xD;
      procedures. As a result, open abdominal sacrocolpopexy with Burch colposuspension has fallen&#xD;
      out of favor, and minimally invasive laparoscopic sacrocolpopexy is performed with greater&#xD;
      frequency. Additionally, midurethral slings (MUS) have become the gold standard surgical&#xD;
      procedure for the treatment of SUI and are performed more frequently than Burch&#xD;
      colposuspension at the time of prolapse surgery. The Outcomes Following Vaginal Prolapse&#xD;
      Repair and Midurethral Sling (OPUS) study examined the placement of prophylactic MUS at the&#xD;
      time of vaginal prolapse surgery. Patients with MUS had lower rates of SUI than control group&#xD;
      at 3 months (23.6% vs 49.4%) and at 12 months (27.3% vs 43%). However, unlike the CARE trial,&#xD;
      patients with concomitant anti-incontinence procedure had higher rates of adverse events&#xD;
      including bladder perforation (6.7% vs 0%), UTI (31.0% vs 18.3%), major bleeding (3.1% vs&#xD;
      0%), and incomplete bladder emptying at 6 weeks (3.7% vs 0%). In addition, MUS carries the&#xD;
      risk of mesh erosion into the vagina or urinary tract.&#xD;
&#xD;
      By studying the addition of laparoscopic (including robotic) Burch colposuspension to&#xD;
      laparoscopic sacrocolpopexy, the investigators anticipate optimizing surgical outcomes and&#xD;
      minimizing complications for patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">September 27, 2022</completion_date>
  <primary_completion_date type="Actual">September 27, 2022</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>
    <intervention_model_description>Enrolled subjects will be assigned to one of two treatment groups with equal probability. A randomly permuted blocked randomization schema will be generated and maintained by a statistician not otherwise involved in the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The study surgeons will provide clinical care to study participants, and therefore blinding the surgeon to treatment allocation is not feasible. However, we intend that all outcomes assessors and participants will be blinded to treatment allocation until 3-months outcomes are collected.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stress Urinary Incontinence</measure>
    <time_frame>3 months following study intervention</time_frame>
    <description>Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following:&#xD;
A positive retro-fill cough stress test at 300mL&#xD;
Answer of &quot;yes&quot; to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20)&#xD;
Any treatment for stress urinary incontinence after the study surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary Urgency Incontinence</measure>
    <time_frame>3 months following study intervention</time_frame>
    <description>Rate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following:&#xD;
Answer of &quot;yes&quot; to question #16 of Pelvic Floor Distress Inventory 20 (PFDI-20)&#xD;
Any treatment for urgency urinary incontinence after the study surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Symptoms</measure>
    <time_frame>at 2 weeks and again at 3 months following study intervention</time_frame>
    <description>Compare Urinary Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #15-20. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Urinary Retention</measure>
    <time_frame>2 weeks and 3 months following study intervention</time_frame>
    <description>Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Urinary Tract Infection</measure>
    <time_frame>2 weeks and 3 months following study intervention</time_frame>
    <description>Rate of Urinary Tract Infection, defined as a positive urine culture obtained from a straight catheterized urine specimen, from participants with symptoms of urinary tract infection (fever, dysuria, urinary urgency, urinary frequency).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic Organ Prolapse Symptoms</measure>
    <time_frame>at 2 weeks and again at 3 months following study intervention</time_frame>
    <description>Compare Pelvic Organ Prolapse Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #1-6. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Symptoms</measure>
    <time_frame>at 2 weeks and again at 3 months following study intervention</time_frame>
    <description>Compare Bowel Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #7-14. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 32.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Function</measure>
    <time_frame>3 months following study intervention</time_frame>
    <description>Compare Sexual Function utilizing the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Surgical Complication</measure>
    <time_frame>2 weeks and 3 months following study intervention</time_frame>
    <description>Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Incontinence,Stress</condition>
  <condition>Urinary Incontinence, Urge</condition>
  <condition>Bowel Dysfunction</condition>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Burch Colposuspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Burch Colposuspension</intervention_name>
    <description>The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.</description>
    <arm_group_label>Laparoscopic Burch Colposuspension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English or Spanish speaking and reading&#xD;
&#xD;
          -  Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen&#xD;
&#xD;
          -  Stress-continent, as defined as response of &quot;no&quot; to question 17 of PFDI-20: &quot;Do you&#xD;
             usually experience urine leakage related to coughing, sneezing, or laughing?&quot;, as well&#xD;
             as a negative empty supine stress test.&#xD;
&#xD;
          -  Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy&#xD;
&#xD;
          -  Have completed childbearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Pregnant women or patients desiring future pregnancy&#xD;
&#xD;
          -  Patients undergoing uterine sparing surgery&#xD;
&#xD;
          -  Individuals under age 18&#xD;
&#xD;
          -  Prior procedure for stress urinary incontinence&#xD;
&#xD;
          -  Prior retropubic 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>Sarah A Collins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Hospital</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.</citation>
    <PMID>24807341</PMID>
  </reference>
  <reference>
    <citation>Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.</citation>
    <PMID>16611949</PMID>
  </reference>
  <reference>
    <citation>Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.</citation>
    <PMID>22716974</PMID>
  </reference>
  <reference>
    <citation>Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.</citation>
    <PMID>19037026</PMID>
  </reference>
  <reference>
    <citation>Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30. doi: 10.1089/end.2006.0381.</citation>
    <PMID>17867956</PMID>
  </reference>
  <reference>
    <citation>Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.</citation>
    <PMID>15902189</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Sarah Collins</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Burch Colposuspension</keyword>
  <keyword>Sacrocolpopexy</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Robotic Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT03841513
org study id: STU00208016
nct id: NCT03841513
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the
      time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the
      participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and
      half of the participants will undergo sacrocolpopexy alone.
In the United States it is estimated that 13% of women will undergo surgery for POP by age
      80. In patients without symptoms of stress urinary incontinence (SUI), surgical correction of
      pelvic organ prolapse (POP) by itself can result in postoperative occult SUI. Two multicenter
      randomized trials of stress-continent women undergoing vaginal or open prolapse surgery
      showed lower rates of postoperative SUI if patients undergo concomitant anti-incontinence
      procedures. However, adverse outcomes vary based on the type of anti-incontinence procedure
      (open Burch colposuspension or retropubic midurethral sling) and route of surgery (open or
      vaginal), and therefore the preferred approach to address occult SUI is unknown.

      Sacrocolpopexy is the gold standard surgical repair of pelvic organ prolapse of the apical
      compartment. The Burch colposuspension is a retropubic procedure in which the periurethral
      tissue of the anterior vagina is affixed to Cooper's ligament on either side using permanent
      suture bridges. In the Colpopexy and Urinary Reduction Efforts (CARE) trial patients without
      preoperative symptoms of SUI were randomized to receive or not to receive concomitant
      prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy. At three months,
      the subjects who underwent the Burch procedure were found to have lower rates of SUI after
      surgery (33.6%) compared to the control group (57.4%). Furthermore, of patients who tested
      negative for SUI on preoperative urodynamic testing, 22.9 % of those who underwent the Burch
      procedure had SUI compared to 47.9% in the control group. Burch colposuspension did not
      increase the rate of urinary retention, urge incontinence, urinary urgency, urinary tract
      infection, intra or post-operative complications. The data in this trial supported the
      placement of prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy.

      Over the last decade, there has been a shift away from open routes of surgical access
      secondary to decreased morbidity and quicker recovery associated with minimally invasive
      procedures. As a result, open abdominal sacrocolpopexy with Burch colposuspension has fallen
      out of favor, and minimally invasive laparoscopic sacrocolpopexy is performed with greater
      frequency. Additionally, midurethral slings (MUS) have become the gold standard surgical
      procedure for the treatment of SUI and are performed more frequently than Burch
      colposuspension at the time of prolapse surgery. The Outcomes Following Vaginal Prolapse
      Repair and Midurethral Sling (OPUS) study examined the placement of prophylactic MUS at the
      time of vaginal prolapse surgery. Patients with MUS had lower rates of SUI than control group
      at 3 months (23.6% vs 49.4%) and at 12 months (27.3% vs 43%). However, unlike the CARE trial,
      patients with concomitant anti-incontinence procedure had higher rates of adverse events
      including bladder perforation (6.7% vs 0%), UTI (31.0% vs 18.3%), major bleeding (3.1% vs
      0%), and incomplete bladder emptying at 6 weeks (3.7% vs 0%). In addition, MUS carries the
      risk of mesh erosion into the vagina or urinary tract.

      By studying the addition of laparoscopic (including robotic) Burch colposuspension to
      laparoscopic sacrocolpopexy, the investigators anticipate optimizing surgical outcomes and
      minimizing complications for patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled subjects will be assigned to one of two treatment groups with equal probability. A randomly permuted blocked randomization schema will be generated and maintained by a statistician not otherwise involved in the study.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The study surgeons will provide clinical care to study participants, and therefore blinding the surgeon to treatment allocation is not feasible. However, we intend that all outcomes assessors and participants will be blinded to treatment allocation until 3-months outcomes are collected.
measure: Stress Urinary Incontinence
time frame: 3 months following study intervention
description: Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following:
A positive retro-fill cough stress test at 300mL
Answer of "yes" to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20)
Any treatment for stress urinary incontinence after the study surgery
measure: Urinary Urgency Incontinence
time frame: 3 months following study intervention
description: Rate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following:
Answer of "yes" to question #16 of Pelvic Floor Distress Inventory 20 (PFDI-20)
Any treatment for urgency urinary incontinence after the study surgery
measure: Urinary Symptoms
time frame: at 2 weeks and again at 3 months following study intervention
description: Compare Urinary Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #15-20. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.
measure: Rate of Urinary Retention
time frame: 2 weeks and 3 months following study intervention
description: Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
measure: Rate of Urinary Tract Infection
time frame: 2 weeks and 3 months following study intervention
description: Rate of Urinary Tract Infection, defined as a positive urine culture obtained from a straight catheterized urine specimen, from participants with symptoms of urinary tract infection (fever, dysuria, urinary urgency, urinary frequency).
measure: Pelvic Organ Prolapse Symptoms
time frame: at 2 weeks and again at 3 months following study intervention
description: Compare Pelvic Organ Prolapse Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #1-6. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.
measure: Bowel Symptoms
time frame: at 2 weeks and again at 3 months following study intervention
description: Compare Bowel Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #7-14. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 32.
measure: Sexual Function
time frame: 3 months following study intervention
description: Compare Sexual Function utilizing the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 48.
measure: Rate of Surgical Complication
time frame: 2 weeks and 3 months following study intervention
description: Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.
arm group label: Control
arm group type: No Intervention
description: Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
arm group label: Laparoscopic Burch Colposuspension
arm group type: Active Comparator
description: Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
intervention type: Procedure
intervention name: Laparoscopic Burch Colposuspension
description: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
arm group label: Laparoscopic Burch Colposuspension
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah A Collins, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
country: United States
citation: Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PMID: 24807341
citation: Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
PMID: 16611949
citation: Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PMID: 22716974
citation: Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
PMID: 19037026
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PMID: 17867956
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PMID: 15902189
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Sarah Collins
investigator title: Assistant Professor
mesh term: Intestinal Diseases
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Urinary Incontinence, Urge
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No