E-CARE Derived Analysis Dataset: PFDI, CSV in Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse: The Extended Colpopexy and Urinary Reduction Efforts (E-CARE) Study

Derived dataset created to produce UDI, POPDI, and CRADI summary scores from the PFDI EQOL form
Study Description
This study extended follow-up of eligible women enrolled in the CARE (Colpopexy and Urinary Reduction Effort) trial, a two year randomized trial designed to assess whether a Burch colposuspension, when added to a planned sacrocolpopexy for the treatment of prolapse, improves the rate of urinary stress continence in subjects without pre-operative symptoms of stress urinary incontinence. Participants were followed for up to 10 years from the time of their initial surgery completed during the CARE trial. The trial concluded that during 7 years of long-term follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented stress urinary incontinence longer than no urethropexy. Researchers concluded that abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. Adult women who were enrolled in A Randomized Trial of Colpopexy and Urinary Reduction Efforts (CARE Trial) who provided informed consent and were not long-term residents of a skilled nursing facility.