Abstract
IMPORTANCE: More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. OBJECTIVES: To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). DESIGN, SETTING, AND PARTICIPANTS: Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. MAIN OUTCOMES AND MEASURES: Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. RESULTS: By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). CONCLUSIONS AND RELEVANCE: During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00099372.