A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Continued usage with satisfaction
研究概览
简要总结
This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Symptomatic pelvic organ prolapse of stage II~IV
- •Ability to participate in clinical trial and follow-up
- •The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent
排除标准
- •Acute phase of infection of the internal and/or external genital tracts
- •Genital fistula
- •Suspected or untreated lower genital tract tumors
- •Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
- •Life expectancy less than 1 year
- •Cognitive or language communication disorders
- •Unable to watch video (e.g., blindness)
结局指标
主要结局
Continued usage with satisfaction
时间窗: 12 months after pessary fitting.
Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.
次要结局
- Willingness to treatment(Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.)
- Anxiety about pessary use(Baseline and at pessary fitting.)
- Improvement in symptoms(3 and 12 months after successful pessary fitting.)
- Treatment-related symptoms and complications(3 and 12 months after successful pessary fitting.)
- Knowledge of pessary(Baseline and at pessary fitting.)
- Ability to self-manage(3 and 12 months after successful pessary fitting.)
- Improvement in quality of life(3 and 12 months after successful pessary fitting.)
- Improvement in sexual activity(3 and 12 months after successful pessary fitting.)