NCT02162615已完成不适用
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 48
- 主要终点
- Rate of device and procedure related serious adverse events
研究概览
简要总结
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female at least 18 years of age
- •Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
- •Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
- •Subject is willing to provide written informed consent
- •Subject is willing and able to comply with the follow-up regimen
排除标准
- •Subject is pregnant or intends to become pregnant during the study
- •Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
- •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), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- •Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
- •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •Subject has uncontrolled diabetes mellitus (DM)
- •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 is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- •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 has a known sensitivity to polypropylene
- •Subject has had previous prolapse repair with mesh in the target compartment(s)
- •Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair
结局指标
主要结局
Rate of device and procedure related serious adverse events
时间窗: 12 Month
Recurrence of Prolapse
时间窗: 12 Month
Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
次要结局
- Recurrence of Prolapse(36 Month)
- Device or Procedure related AEs of interest(36 months)
研究者
研究点 (48)
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