Dutch Title: Zelfmanagement Pessarium Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Number of patients that succeed in learning self-management of the pessary
研究概览
简要总结
The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse.
The primary question it aims to answer is:
• how many patients succeed learning self-management if offered a standardized training?
Secondary outcomes are:
- how many patients are willing to learn self-management?
- what patient factors contribute to successfully learning self-management and willingness to self-manage?
- how satisfied are patients with pessary therapy and self-management?
- the occurrence of side-effects
- continuation and quitting of pessary therapy and self-management
- cross-over to surgery
- number of visits to doctor because of pessary therapy
- healthcare costs
Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary).
Researchers will compare the self-managing patient to the non-self-managing patients.
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
- •fitted a ring, sieve of knob pessary
- •above 18 years old
- •able to understand patient information
排除标准
- •fitted a new pessary to replace an old one (continuing former pessary therapy)
- •fitted a new pessary after they experienced adverse effects of a former pessary
结局指标
主要结局
Number of patients that succeed in learning self-management of the pessary
时间窗: immediately after self-management training, it is determined whether patients can remove and insert their pessary
Patients were offered self-management training, after explanation they were asked to remove and insert their pessary twice. Succes was defined as removing and inserting the pessary completely independent the second time.
次要结局
未报告次要终点