NCT04829058终止不适用
A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
研究概览
简要总结
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- •Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
- •GYNEMESH PS Mesh was used as a bridging material according to the IFU.
- •Able and willing to participate in follow-up
- •Subject or authorized representative has signed the approved informed consent
排除标准
- •Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- •Subjects < 21 years of age at the time of informed consent
- •Subjects who had transvaginal approach for surgery
- •Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
结局指标
主要结局
Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
时间窗: Post-surgery through study completion, approximately 7 yrs
Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.
次要结局
- Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire(Post-surgery through study completion, approximately 7yrs)
- Pelvic Floor Distress Inventory (PFDI-20) Questionnaire(Post-surgery through study completion, approximately 7yrs)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)(Post-surgery through study completion, approximately 7yrs)
研究者
研究点 (7)
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