Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse
研究概览
简要总结
Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can be surgical or conservative using vaginal pessaries. These devices are introduced into the vagina aiming to reduces the prolapse.
Pessaries have shown effectiveness in improving symptoms and quality of life. There are no randomized studies comparing them with surgery. This study design would be difficult to perform, because the inclusion criteria for both treatments are different. There are no currently standard protocols for the use of pessaries. This makes harder to widespread the usage of this conservative treatment.
The aim of the investigators is to identify variables that influence the success of conservative management of genital prolapse at 1 year of follow up. Using these variables and an expert panel opinion the investigators will develop a standardized protocol for pessary management.
Chile has a primary gynecological care system based midwives. Therefore having algorithms for pessaries usage becomes relevant. This algorithm can be implemented with basic training. This would increase the respond capacity, by the health care system to this disease, considering the scarce access to surgery.
The investigators hypothesis is: It is possible to generate a standardized protocol of conservative management of symptomatic genital prolapse in patient's beneficiary of public health system in Santiago, Chile, using pessaries through a prospective cohort study based in the success of these devices with 1 year of follow up, measured with questionnaires of symptoms, quality of life and sexuality
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Commitment to attend controls
- •Current negative cervical cytology
- •Informed consent signed
排除标准
- •Urinary incontinence as the only Pessary Indication
- •Vaginal bleeding of undetermined cause
- •Unable to return to controls
结局指标
主要结局
Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse
时间窗: 6 months and 12 months
At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes
Successful usage of pessary
时间窗: 12 months
If an enrolled patients is still using the pessary as the treatment for the pelvic organ prolapse will be considered as "successful". Risk factors for unsuccessful pessary used will be measure using baseline characteristics.
Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse
时间窗: 6 months and 12 months
At baseline, 6 and 12 month the Chilean Version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) survey will be applied to describe the Sexually response changes
Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse
时间窗: 6 months and 12 months
At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement
Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse
时间窗: 6 months and 12 months
At baseline, 6 and 12 month the Chilean Version of the Pelvic Distress Inventory - 20 (PDFI-20) survey will be applied to describe the symptoms changes
次要结局
未报告次要终点