Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Gastrointestinal, Urology, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | January 29, 2019 |
| End Date: | March 2020 |
| Contact: | Meera Tavathia, MPH |
| Email: | meera.tavathia@nm.org |
| Phone: | 3129267846 |
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.
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.
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.
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
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Sarah A Collins, MD
Phone: 312-926-7846
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