Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 12
- 主要终点
- Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
研究概览
简要总结
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
详细描述
This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.
The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.
The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
- •Require both apical and anterior compartment repairs
- •Willing to return for follow-up visit
- •Understand and have signed informed consent to undergo randomization
- •Need both an apical and anterior repair
- •All trial participants who have a uterus will require a hysterectomy
排除标准
- •Known or suspected vulvodynia
- •Known or suspected interstitial cystitis
- •History of chronic pelvic pain
- •Current pregnancy
- •Desire to maintain fertility
- •History of reconstructive pelvic surgery with synthetic mesh
- •History of radical pelvic surgery
- •History of pelvic radiation therapy
- •Currently undergoing treatment for a malignancy
- •Medically poor candidates for surgery
结局指标
主要结局
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
时间窗: 12 months
Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.
次要结局
未报告次要终点
研究者
Emanuel Trabuco
Assistant Professor of Obstetrics-Gynegology, Consultant-OB/Gyn Surgery
Mayo Clinic