Calistar A vs. Calistar S - Cohort Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Percentage of Cured Participants According to Barber Criteria
研究概览
简要总结
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).
详细描述
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI)
- •Primary or recurrent treatment with Calistar S or Calistar A
- •At least 6 months follow-up
排除标准
- •Recurrent vaginal infections,
- •Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis).
- •Presence of any coagulopathies,
- •Impairment of the immune system or any condition that compromises recovery,
- •Prior irradiation
- •Chronic pelvic pain
结局指标
主要结局
Percentage of Cured Participants According to Barber Criteria
时间窗: Post-operative at 6 months
According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.
次要结局
- Adverse Events(Intra-operative and post-operative at 6 months)
- Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)(Pre-operative and post-operative at 6 months)
- Quality of Life Status: Patient Global Impression Questionnaire(Post-operative at 6 months)
研究者
Agustin Sampietro
Gynecologist
University of Buenos Aires