Abdominal sacrocolpopexy, with or without concomitant urethropexy, "is less effective than desired" for long-term treatment of pelvic organ prolapse, according to a report in the May 15 issue of JAMA.
In extended follow-up of 215 women who had undergone the surgery in 2001-2006 to correct pelvic organ prolapse (POP), nearly one-third of the procedures had failed at the 7-year mark. And for women whose surgery involved the placement of synthetic mesh, the estimated probability of mesh erosion was 10.5%, said Dr. Ingrid Nygaard of the University of Utah, Salt Lake City, and her associates.
Nevertheless, only 5% of the women in this study sought retreatment for POP – a result that the investigators interpreted to mean that the procedures had addressed their symptoms adequately.
"Based on our results, women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from POP symptoms; however, the anatomic support deteriorates over time," they said.
"Surgical counseling about the ongoing risk of mesh-related events even for abdominal sacrocolpopexy is critical. Women should be aware that symptoms such as vaginal bleeding, discharge, and pain may be due to mesh erosion and should seek help accordingly," the researchers noted (JAMA 2013;309:2016-24).
Even though some 225,000 women in the United States undergo POP surgeries every year, "little is known about long-term durability, complications, and pelvic floor symptoms" associated with the procedure. To examine the issue, Dr. Nygaard and her colleagues performed an extended follow-up of women who had participated in the CARE (Colpopexy and Urinary Reduction Efforts) trial, which concluded in 2006.
CARE was a multicenter trial funded by the National Institutes of Health in which 322 women who did not have stress urinary incontinence and were undergoing abdominal sacrocolpopexy were randomly assigned to concomitant Burch urethropexy (to prevent the common postoperative adverse effect of stress urinary incontinence) or to serve as controls. At 2 years, the incidence of stress urinary incontinence was 32.0% in women who had the prophylactic urethropexy, significantly lower than the 45.2% incidence in the control group.
Dr. Nygaard and her associates were able to follow up on 215 of these CARE participants up to 7 years later. "We were surprised by the magnitude of treatment failure rates," they said.
"By year 7, the estimated probabilities of treatment failure for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic pelvic organ prolapse, 0.29 and 0.24 for symptomatic pelvic organ prolapse, and 0.48 and 0.34 for composite pelvic organ prolapse," the investigators said.
The estimated probability that in a few years the women would develop stress urinary incontinence was 0.62 for those who had undergone urethropexy specifically to prevent that adverse effect and 0.77 for those who had not undergone urethropexy.
In addition, by year 7, 4 women had suture erosion and 23 had mesh erosion. Mesh erosion occurred with every type of mesh that had been placed.
"By year 7, at least 36 of 215 women (16.7%) ... had additional surgery related to pelvic floor disorders: 11 for recurrent POP, 14 for stress urinary incontinence, and 11 for mesh complications," the investigators said.
Their findings have three important implications.
"First, as a criterion standard for surgical treatment of POP, abdominal sacrocolpopexy is less effective than desired.
"For this study, we chose a clinically relevant definition of anatomic failure that some would argue is still not stringent enough, yet by 5 years, nearly one-third of women met our composite failure definition," they noted.
Nevertheless, the procedure generally appears to relieve POP symptoms, even though anatomic support wanes. Only 5% of the study population sought retreatment for POP, which "may imply that women found the treatment adequate," Dr. Nygaard and her colleagues said.
Second, "surgical prevention of stress urinary incontinence at the time of abdominal POP surgery involves no clinically significant trade-offs to date." Adding an anti–urinary-incontinence procedure to sacrocolpopexy decreases but does not eliminate the risk that such incontinence will develop.
And third, mesh-related complications continue to develop over time. "Long-term follow-up is mandatory to understand the long-term patient burden associated with surgical materials and devices," they said.
One limitation of this study was that participants at some sites could not be followed at all, and participants at other sites could only be followed by telephone interview rather than physical examination, because research funding for that purpose was not renewed over time.
The researchers added that clinical practice has shifted since the original CARE trial was conducted; midurethral slings are now more commonplace, and sacrocolpopexy now is often performed via laparoscopic or even robotic approaches. "It is unclear to what degree [our] results can be extrapolated to the newer procedures because we only evaluated open abdominal sacrocolpopexy and Burch urethropexy."