NCT00099372

Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse

Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 215 (actual)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The Colpopexy and Urinary Reduction Effort (CARE) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (POP) affects the rates of urinary incontinence. This study will follow women in the CARE study for 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in CARE. Recruitment into CARE is closed.

Detailed description

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.

Conditions

• Prolapse
• Urinary Incontinence

Timeline

• Start date: 2004-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2004-12-13
• Last updated: 2021-03-22
• Results posted: 2021-03-22

Locations

8 sites across 1 country: United States