ASPIRe Body Image in Pelvic Organ Prolapse Form in Three-Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair

ASPIRe Body Image in Pelvic Organ Prolapse Form, CSV
Study Description
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. Adult women 21 years or older with prior total hysterectomy who sought surgical treatment for bothersome bulge symptoms due to prolapse beyond the hymen.

ASPIRe盆腔器官脱垂身体意象问卷（ASPIRe Body Image in Pelvic Organ Prolapse Form），CSV格式
研究概况
ASPIRe试验为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植入术（apical transvaginal mesh placement）在子宫切除术后阴道穹窿脱垂的解剖学矫正效果方面是否不劣于骶骨阴道固定术（sacral colpopexy），并对比经腹或经阴道路径实施的网片加固修补术与自体组织阴道修补术（native tissue vaginal repair）的优劣。
术后对受试者开展最长60个月的随访，所有试验组均报告主观结局指标得到持续改善。
接受阴道穹窿脱垂顶端修补术、骶骨阴道固定术与经阴道网片修补术的受试者，其复合失败率相近，且二者的失败率均低于自体组织阴道修补术。
网片暴露（mesh exposure）、性交痛（dyspareunia）与不良事件（adverse events）的总体发生率均较低。
本研究的纳入标准为年龄21岁及以上、曾接受全子宫切除术，且因处女膜外脱垂引发令人困扰的膨出症状而寻求手术治疗的成年女性。