- Moderator Neeraj Kohli, MD, MBA OBG Management Board of Editors Director, Division of Urogynecology, Brigham and Women’s Hospital, and Assistant Professor, Harvard Medical School, Boston.
- Lead investigator of the CARE trial Linda Brubaker, MD, MS, Professor and Director, Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago.
- Mark D. Walters, MD, Head, Section of General Gynecology, Urogynecology, and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, Ohio.
- Anne M. Weber, MD, MS, Program Officer, Pelvic Floor Disorders Network, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md. Dr. Weber is an investigator in the CARE Trial.
Why should we care about the CARE (Colpopexy and Urinary Reduction Efforts) trial?
Because pelvic organ prolapse and urinary incontinence are already major problems facing women as they age, and will become even more pervasive as the baby boomer generation moves through menopause and beyond.
Because roughly one third of women who undergo prolapse or incontinence surgery require a second operation.
These are just a few of the factors that spurred the Pelvic Floor Disorders Network to undertake the CARE trial, published April 13 in the New England Journal of Medicine. OBG Management convened a panel of experts in female pelvic medicine, including 2 CARE trial investigators, to discuss the findings of this landmark study, its long-term implications, and the future of research into pelvic floor disorders.
How the trial was conducted
The CARE trial involved 322 women who required surgery to correct pelvic organ prolapse (POP) but lacked symptoms of stress urinary incontinence. All these women underwent sacrocolpopexy, an abdominal procedure in which graft material is attached between the vagina and sacrum to support the vagina and correct the prolapse. These women were randomized to undergo Burch colposuspension at the time of the sacrocolpopexy, or to undergo sacrocolpopexy only. The Burch procedure is performed through the same incision as the sacrocolpopexy and involves suturing the periurethral vaginal tissue to the iliopectineal ligaments on each side, providing urethral support.
Enrollment in the trial was halted after the first of 2 planned interim analyses because the frequency of postoperative stress incontinence was significantly lower in the group undergoing Burch colposuspension: 23.8% and 44.1% of women in the Burch and no-Burch groups, respectively, experienced stress symptoms by 3 months after the surgery.
Why the CARE trial is an epochal event
- First randomized trial of preventive incontinence surgery in women with prolapse
- Randomized design establishes cause and effect
- Subjects will be followed for 2 years
BRUBAKER: First, it is a well-designed, randomized, controlled trial and thus provides the highest level of evidence for clinical practice. Although there is no perfect study, this one minimized the risk of bias by involving multiple centers (7) and using multiple surgeons, making the findings more generalizable than would be the case in a single-surgeon case series.
In addition, the use of blinded urodynamic testing lent strength, because the ability of urodynamic testing to predict the need for a concomitant continence procedure was not known before the trial. Our follow-up manuscript, containing data presented at the recent Society of Gynecologic Surgeons meeting, will provide more details on this aspect of the trial.
WEBER: Randomized trials are held in such high esteem—provided all other aspects of study design and implementation are performed properly—because they support conclusions of cause and effect. The conclusion that Burch colposuspension prevents stress incontinence when performed at the time of abdominal sacrocolpopexy could only be drawn from a randomized trial.