NL-OMON46901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
- 发起方
- Coloplast
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is female
- •2. Subject is at least 18 years of age
- •3. 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
- •4. 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*)
- •5. Subject is willing to provide written informed consent
- •6. Subject is willing and able to comply with the follow-up regimen
排除标准
- •1. Subject is pregnant or intends to become pregnant during the study
- •2. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
- •3. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- •4. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- •5. Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- •6. Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
- •7. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •8. Subject has uncontrolled diabetes mellitus (DM)
- •9. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
- •10. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- •11. Subject is not able to conform to the modified dorsal lithotomy position
- •12. Subject is currently participating in or plans to participate in another device or drug study during this study
- •13. Subject has a known sensitivity to polypropylene (Restorelle mesh arm only)
- •14. Subject has had previous prolapse repair with mesh in the target compartment(s)
- •15. Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair
研究者
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