Three-Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair

The ASPIRe trial was a multi-site, three-arm randomized controlled clinical trial to determine if apical transvaginal mesh placement is non-inferior to sacral colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse and to determine if mesh reinforced repairs performed by abdominal or vaginal approach are superior to native tissue vaginal repair. After surgery, participants were followed for up to sixty months and all arms reported sustained improvement in subjective outcomes. Participants who underwent apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates and both had lower failure rates than native tissue repair. Overall rates of mesh exposure, dyspareunia, and adverse events were low.

ASPIRe试验是一项多中心、三臂随机对照临床试验，旨在评估经阴道顶端网片置入术在子宫切除术后阴道穹窿脱垂解剖矫正方面是否不劣于骶骨阴道固定术，并确定通过腹腔或阴道途径进行的网片增强修复是否优于自体组织阴道修复。术后，参与者随访长达60个月，所有试验组均报告主观结局持续改善。接受阴道穹窿脱垂顶端修复（骶骨阴道固定术和经阴道网片术）的参与者，其复合失败率相似，且两者均低于自体组织修复。网片暴露、性交困难和不良事件的总体发生率较低。