NCT06234449尚未招募不适用
The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.
研究概览
简要总结
Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pelvic organ prolapse with POP-Q stage >/= 3 in anterior and/or central compartments
- •Women between 45 and 80 years old
排除标准
- •Women who refuse to participate in the study
- •Patients without baseline POPQ examination documented or with a pessary previously positioned
- •Previous pelvic surgeries
- •Women with any contraindication for surgery or preference for conservative treatment only (pelvic muscle exercise, vaginal pessary)
- •Women who are not successfully fitted with pessaries
- •Current genital ulcers/infections
- •Active or chronic pelvic infection
- •Women who are mentally incapable of completing the questionnaires.
结局指标
主要结局
evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.
时间窗: At the time of surgery procedure, after at least 6 months after pessary placement
Primary endopoint is the evaluation of the percentage of women who experience a change in any POPQ point on examination at the time of surgery from baseline evaluation.
次要结局
未报告次要终点
研究者
Stefano Salvatore
Professor
IRCCS San Raffaele
研究点 (1)
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