NCT02021279已完成不适用
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 26
- 主要终点
- The safety and effectiveness of surgical success/failure.
研究概览
简要总结
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject's leading edge of POP is at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥ 0 or Bp ≥ 0 or C ≥ 0 (for prolapse of the apical compartment alone) or C ≥ -½ total vaginal length (for a multi-compartment prolapse that includes the apical compartment).
- •Subject is seeking surgical intervention for symptomatic POP, which is defined as experiencing symptoms of vaginal bulging or pelvic heaviness. Vaginal bulge or pelvic heaviness will be considered present if a subject responds "yes" (≥1) to PFDI-20, question
- •Subject or subject's legally authorized representative is willing to provide written informed consent.
- •Subject is willing and able to comply with the follow-up regimen.
排除标准
- •Subject has a known hypersensitivity to porcine-based materials (relevant to subjects in MatriStem Pelvic Floor Matrix Group only).
- •Subject is pregnant or plans to become pregnant during the study.
- •Subject has an active or chronic systemic infection including any gynecologic infection, urinary tract infection (UTI), or tissue necrosis.
- •Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit).
- •Subject has chronic systemic pain syndrome (e.g. fibromyalgia, painful bladder syndrome).
- •Subject has a systemic connective tissue disease (e.g., scleroderma, systemic lupus erythematous (SLE), Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica).
- •Subject has uncontrolled diabetes mellitus (DM).
- •Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
- •Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
- •Subject has taken systemic steroids (within the last month), immunosuppressive or immunomodulatory treatment (within the last 3 months).
- •Subject is seeking obliterative vaginal surgery as treatment for POP (colpoclesis).
- •Subject is not able to conform to the modified dorsal lithotomy position.
- •Subject is currently participating in or plans to participate in another device or drug study during this study.
- •Subject is to planning to undergo concurrent surgical treatment of prolapse using mesh other than the MatriStem Pelvic Floor Matrix.
结局指标
主要结局
The safety and effectiveness of surgical success/failure.
时间窗: 3 years
The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse.
次要结局
- The surgical success/failure based on an alternate definition of success.(3 years)
研究者
研究点 (26)
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