Pelvic Organ Prolapse Clinical Trial
— MICROOfficial title:
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Verified date | February 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | September 27, 2022 |
Est. primary completion date | September 27, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Prentice Women's Hospital | Chicago | Illinois |
United States | Loyola University Hospital | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Friends of Prentice |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Urinary Urgency Incontinence | 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 |
3 months following study intervention | |
Secondary | Urinary Symptoms | 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. | at 2 weeks and again at 3 months following study intervention | |
Secondary | Rate of Urinary Retention | Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization | 2 weeks and 3 months following study intervention | |
Secondary | Rate of Urinary Tract Infection | 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). | 2 weeks and 3 months following study intervention | |
Secondary | Pelvic Organ Prolapse Symptoms | 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. | at 2 weeks and again at 3 months following study intervention | |
Secondary | Bowel Symptoms | 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. | at 2 weeks and again at 3 months following study intervention | |
Secondary | Sexual Function | 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. | 3 months following study intervention | |
Secondary | Rate of Surgical Complication | Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system. | 2 weeks and 3 months following study intervention |
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