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Two-Year Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence

From the ¹Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois; the ²Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah; the ³Department of Obstetrics and Gynecology, University of Alabama School of Medicine, Birmingham, Alabama; the ⁴Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina; the ⁵Contraception and Reproductive Health Branch, Center for Population Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; the ⁶Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland; the ⁷Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas; the ⁸Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania; and the ⁹Department of Biostatistics, University of Michigan, Ann Arbor, Michigan.

OBJECTIVES: To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension.

METHODS: In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years.

RESULTS: This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 32.0% and 45.2% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.026). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions.

CONCLUSION: The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch.

CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, ClinicalTrials.gov, NCT00065845

LEVEL OF EVIDENCE: I