Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

NCT03841513 | Completed Results

• 1 other identifier: STU00208016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Burch Colposuspension; Sacrocolpopexy; Laparoscopy; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Stress Urinary Incontinence

  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

  3 months following study intervention

Secondary Outcomes (8)

• Number of Participants With Urinary Urgency Incontinence

  3 months following study intervention

• Number of Participate With Urinary Frequency

  3 months following study intervention

• Number of Participants With Urinary Retention

  3 months following study intervention

• Number of Participants With Urinary Tract Infection

  3 months following study intervention

• Pelvic Organ Prolapse Symptoms

  3 months following study intervention

Study Arms (2)

Control

NO INTERVENTION

Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension

Laparoscopic Burch Colposuspension

ACTIVE COMPARATOR

Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension

Procedure: Laparoscopic Burch Colposuspension

Interventions

Laparoscopic Burch Colposuspension PROCEDURE

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.

Laparoscopic Burch Colposuspension

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator

Study Sites (2)

Northwestern University Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Loyola University Hospital

Maywood, Illinois, 60153, United States

Location

Related Publications (6)

• 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 BACKGROUND

• 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.

  PMID: 16611949 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17867956 BACKGROUND

• 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.

  PMID: 15902189 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Intestinal Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases

Results Point of Contact

• Title: Dr Tsung Mou
• Organization: TMC

tmou@tuftsmedicalcenter.org

6176365890

Study Officials

• Sarah A Collins, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 15, 2019
• Study Start: January 29, 2019
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)