Pelvic Organ Prolapse Surgery Long-term Outcomes and Implications for Shared Decision Making Pelvic Organ Prolapse Surgery

Iglesia CB. — Wed, 15 May 2013 00:00:00 GMT

Pelvic floor disorders, including pelvic organ prolapse, urinary incontinence, fecal incontinence, and other sensory disorders of the gastrointestinal and genitourinary tract, are common with nearly 1 in 4 US women having at least 1 pelvic floor condition. In this issue of JAMA, Nygaard and colleagues present findings from the extended Colpopexy and Urinary Reduction Efforts (extended CARE) trial. The original CARE trial was a double-blind randomized trial of 322 women mostly with advanced (stage 3-4) prolapse and without stress incontinence symptoms undergoing an open abdominal synthetic mesh sacrocolpopexy procedure either with or without a urethropexy for prevention of stress urinary incontinence.

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse Outcomes for Pelvic Organ Prolapse

Nygaard I, Brubaker L, Zyczynski HM, et al. — Wed, 15 May 2013 00:00:00 GMT

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

AMA Publishing Group: Incontinence Topic Collection

Pelvic Organ Prolapse Surgery Long-term Outcomes and Implications for Shared Decision Making Pelvic Organ Prolapse Surgery

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse Outcomes for Pelvic Organ Prolapse