E-CARE

The purpose of this study is to extend the follow up of women in the Colpopexy and Urinary Reduction Effort (CARE) study for up to 10 years from the time of their surgery. In this way, we will learn more about how prolapse repair surgery affects women over a long period of time.

The CARE trial is a randomized trial designed to assess whether a Burch colposuspension, when added to a planned sacrocolpopexy for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects without pre-operative symptoms of stress urinary incontinence compared to not performing the Burch colposuspension. The CARE study includes a two-year follow up from the time of surgery. Since the follow up period in CARE is too short to evaluate the long-term sequelae of the procedures, the goal of this study is to extend the follow up of women in the CARE study to 10 years from the time of surgery and to compare the success rates and complication rates of the two groups over this longer period of time. This will also provide data on the long-term success rate and sequelae of the abdominal sacral colpopexy.

The primary aims of this prospective cohort study are:

1. To determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as Stage 0 apical prolapse AND < Stage 2 anterior and posterior prolapse AND no re-operation or pessary treatment for POP), and whether anatomic success differs between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.
2. To determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.
3. To determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant Burch colposuspension at the time of sacrocolpopexy.

STUDY RESULTS

Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H, Gantz M, Fine P, Menefee S, Ridgeway B, Visco A, Warren LK, Zhang M, Meikle S. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA. 2013 May; 309(19): 2016-24.

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Grimes CL, Lukacz ES, Gantz MG, Warren LK, Brubaker L, Zyczynski HM, Richter HE, Jelovsek JE, Cundiff G, Fine P, Visco AG, Zhang M, Meikle S, NICHD Pelvic Floor Disorders Network. What happens to the posterior compartment and bowel symptoms after sacrocolpopexy? evaluation of 5-year outcomes from E-CARE. Female pelvic medicine & reconstructive surgery. 2014 Sep; 20(5): 261-6.

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ClinicalTrials.gov

Read more about this study at clinicaltrials.gov.