Prospective Analysis of Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in Anatomy
研究概览
简要总结
The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. [describe participant population/health conditions]. The main question[s] it aims to answer are:
- Is the leading edge of the prolapse above the hymen
- Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.
详细描述
This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis™ Dermis biologic mesh. They will be followed for a period of 3 years. A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy.
Clinical examination including vaginal wall retraction with or without pelvic ultrasound, POP-Q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)
- •Subjects who have bothersome vaginal bulge based upon symptoms.
- •Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus).
排除标准
- •Subjects who are unable to follow-up.
- •Subjects who cannot complete the validated questionnaires.
- •Subjects that lack competency of the English language.
- •Subjects who decline to be part of the clinical trial.
- •Subjects who do not sign an informed consent.
研究组 & 干预措施
Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh
This is a single are which will be composed of subjects with Stage II or greater pelvic organ prolapse who have agreed to undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh. They will undergo the procedure and be followed for a period of 3 years.
干预措施: Axis Dermis biologic mesh repair for pelvic organ prolapse (Device)
结局指标
主要结局
Improvement in Anatomy
时间窗: Preoperative to 3 years postoperative.
To assess improvement in anatomy with success defined as the leading edge of the prolapse is above the hymen, and no reintervention (surgery or pessary) for pelvic organ prolapse.
Improvement in function
时间窗: Preoperative to 3 years postoperative.
Determine improvement in function based on questionnaire Pelvic Floor Distress Inventory Q#3 "Do you usually have a bulge or something falling out that you can see or fell in the vaginal area?" Answered No, or if Yes: Not at all bothersome.
次要结局
- Assess complications or untoward side effects.(intraoperative to 3 years postoperative)
研究者
Salil Khandwala
Medical director
Michigan Institution of Women's Health PC