The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Number of Participants with Mesh exposure
研究概览
简要总结
This study evaluates the efficacy of adding a human amniotic membrane graft to polypropylene mesh surgery for pelvic prolapse and stress urinary incontinence. The goal is to assess improvements in tissue integration and the reduction of surgical complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pelvic organ prolapse (POP) stage II C or greater, defined as C ≥ +1, in women without prior hysterectomy and/or with a diagnosis of stress urinary incontinence seeking surgical treatment.
- •Ability to understand study information and provide written informed consent.
- •Availability for follow-up for a minimum of 12 months.
排除标准
- •Previous surgery with synthetic mesh (via vaginal or abdominal approach) for POP repair.
- •Known adverse reaction to synthetic meshes.
- •Unresolved or active chronic pelvic pain.
- •History of prior abdominal or pelvic radiation.
- •Contraindication to the planned surgical procedure.
- •Current pregnancy.
研究组 & 干预措施
With amniotic membrane
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.
干预措施: Sacrospinous Hysteropexy with Mesh (Procedure)
without amniotic membrane, surgery alone
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch
干预措施: Sacrospinous Hysteropexy with Mesh (Procedure)
With amniotic membrane
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.
干预措施: Retropubic Mid-urethral Sling (Bottom-Up) (Procedure)
With amniotic membrane
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.
干预措施: Transobturator Mid-urethral Sling (Out-In) (Procedure)
without amniotic membrane, surgery alone
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch
干预措施: Retropubic Mid-urethral Sling (Bottom-Up) (Procedure)
without amniotic membrane, surgery alone
Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch
干预措施: Transobturator Mid-urethral Sling (Out-In) (Procedure)
结局指标
主要结局
Number of Participants with Mesh exposure
时间窗: From enrollment through the end of the 12-month follow-up
Comparison of mesh exposure incidence between the control group and the amniotic membrane group through scheduled postoperative follow-up and self-administered questionnaires.
次要结局
未报告次要终点
研究者
Ileana Sänger
Head of Gynecology, Department of Obstetrics and Gynecology
Hospital General de Agudos J. M. Penna