JAMA · 2013
E-CARE
Extended CARE — 7-Year Follow-up of the CARE Trial

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H, et al. · Pelvic Floor Disorders Network
DOI: 10.1001/jama.2013.4919 · NCT00099372
Design
RCT Extension
Patients
215 of 322
Sites
7 US centers
Follow-up
7 years
Completion
59% at 7yr
Surgical Arms
Arm A · n = 104
Sacrocolpopexy + Burch
Abdominal sacrocolpopexy with Burch colposuspension
Arm B · n = 111
Sacrocolpopexy Alone
Abdominal sacrocolpopexy without Burch
POP Failure at 7 Years (Updated Anatomic Definition)
27%
Burch — Anatomic POP Failure
Updated definition
22%
No Burch — Anatomic POP Failure
Updated definition
0.050
Difference
95% CI −0.161, 0.271 — NS
Composite POP Failure Trajectory
2 yr3 yr5 yr7 yr
Burch 0.220.290.390.48
No Burch 0.180.230.290.34
SUI Outcomes at 7 Years
62%
Burch SUI Failure
at 7 years
77%
No Burch SUI Failure
at 7 years
3.3×
Burch Delayed SUI Onset
131.3 vs 40.2 months
−0.153
Difference (Significant)
95% CI −0.268, −0.030
Mesh Erosion: Probability 10.5% (95% CI 6.8–16.1%) at 7 years. 23 women total. New erosions continued appearing throughout follow-up. 15/23 required OR excision. Mandates long-term surveillance.
Additional Surgeries: At least 36/215 (16.7%) had additional pelvic floor surgery by year 7: 11 POP, 14 SUI, 11 mesh complications.
Clinical Bottom Line

Sacrocolpopexy provides durable symptom relief (95% no POP retreatment at 7 years) despite rising anatomic failure (~27%). Burch delays but does not eliminate SUI (62% vs 77% failure at 7yr). The 10.5% mesh erosion rate with ongoing new erosions mandates long-term surveillance and informed consent counseling.