Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence (MICRO)

• ClinicalTrials.gov Identifier: NCT03841513
• Recruitment Status: Recruiting
• First Posted: February 15, 2019
• Last Update Posted: February 15, 2019
• Sponsor: Northwestern University
• Collaborator: Friends of Prentice
• Information provided by (Responsible Party): Sarah Collins, Northwestern University

Tracking Information

• First Submitted Date: January 23, 2019
• First Posted Date: February 15, 2019
• Last Update Posted Date: February 15, 2019
• Actual Study Start Date: January 29, 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 13, 2019)

Stress Urinary Incontinence [ Time Frame: 3 months following study intervention ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 13, 2019)

• Urinary Urgency Incontinence [ Time Frame: 3 months following study intervention ]
  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
• Urinary Symptoms [ Time Frame: at 2 weeks and again at 3 months following study intervention ]
  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.
• Rate of Urinary Retention [ Time Frame: 2 weeks and 3 months following study intervention ]
  Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
• Rate of Urinary Tract Infection [ Time Frame: 2 weeks and 3 months following study intervention ]
  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).
• Pelvic Organ Prolapse Symptoms [ Time Frame: at 2 weeks and again at 3 months following study intervention ]
  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.
• Bowel Symptoms [ Time Frame: at 2 weeks and again at 3 months following study intervention ]
  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.
• Sexual Function [ Time Frame: 3 months following study intervention ]
  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.
• Rate of Surgical Complication [ Time Frame: 2 weeks and 3 months following study intervention ]
  Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
• Official Title: Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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.

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.

Primary Purpose: Treatment

Condition

• Pelvic Organ Prolapse
• Urinary Incontinence,Stress
• Urinary Incontinence, Urge
• Bowel Dysfunction
• Sexual Dysfunction

Intervention

Procedure: Laparoscopic Burch Colposuspension

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.

Study Arms

• No Intervention: Control
  Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
• Active Comparator: Laparoscopic Burch Colposuspension
  Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
  Intervention: Procedure: Laparoscopic Burch Colposuspension

Publications *

• 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):1201-6. doi: 10.1097/AOG.0000000000000286.
• 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. Erratum in: N Engl J Med. 2016 Jun 9;374(23):2297-8.
• 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.
• Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-6. doi: 10.1097/AOG.0b013e31818ce394.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 13, 2019): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2020
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• English or Spanish speaking and reading
• Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen
• Stress-continent, as defined as response of "no" to question 17 of PFDI-20: "Do you usually experience urine leakage related to coughing, sneezing, or laughing?", as well as a negative empty supine stress test.
• Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy
• Have completed childbearing

Exclusion Criteria:

• Adults unable to consent
• Pregnant women or patients desiring future pregnancy
• Patients undergoing uterine sparing surgery
• Individuals under age 18
• Prior procedure for stress urinary incontinence
• Prior retropubic surgery

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Meera Tavathia, MPH; 3129267846; meera.tavathia@nm.org

Contact: Akira Gillingham, MD; 3124724023; akira.gillingham@nm.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03841513
• Other Study ID Numbers: STU00208016
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sarah Collins, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Friends of Prentice

Investigators

• Principal Investigator: Sarah A Collins, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: February 2019