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

Health Utilities Index form data
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.

健康效用指数（Health Utilities Index）量表数据
研究概况
本研究针对纳入CARE（阴道骶骨固定术与尿道减压研究，Colpopexy and Urinary Reduction Effort）试验的符合条件女性开展延长随访。CARE试验为一项为期两年的随机对照试验，旨在评估在计划用于治疗盆腔器官脱垂的骶骨阴道固定术（sacrocolpopexy）基础上附加Burch阴道尿道悬吊术（Burch colposuspension），能否提升无术前压力性尿失禁（stress urinary incontinence）症状受试者的压力性尿失禁控制率。受试者自CARE试验期间完成首次手术起，最长随访时长达10年。
该试验结论显示，在7年的长期随访中，两组受试者的经腹骶骨阴道固定术（abdominal sacrocolpopexy）失败率均有所上升；尿道悬吊术（urethropexy）在预防压力性尿失禁方面的持续效果优于未行尿道悬吊术者。研究人员得出结论：经腹骶骨阴道固定术的临床疗效，需与补片（mesh）或缝线侵蚀（suture erosion）的长期风险进行权衡。本研究纳入对象为曾参与《阴道骶骨固定术与尿道减压随机对照试验（CARE试验）》、已签署知情同意书且并非专业护理机构长期住客的成年女性。