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

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

Tracking Information
First Submitted Date  ICMJE January 23, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Pelvic Organ Prolapse
  • Urinary Incontinence,Stress
  • Urinary Incontinence, Urge
  • Bowel Dysfunction
  • Sexual Dysfunction
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meera Tavathia, MPH 3129267846 meera.tavathia@nm.org
Contact: Akira Gillingham, MD 3124724023 akira.gillingham@nm.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03841513
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Sarah Collins, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Friends of Prentice
Investigators  ICMJE
Principal Investigator: Sarah A Collins, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP