ChiCTR2000034613尚未招募不适用
陰道子宮托治療盆腔器官脫垂與應力性尿失禁的隨機對照試驗
Departmental Funding2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reduction in the PFDI Urinary Distress Inventory scores between both groups at 6 months and 12 months after treatment
研究概览
简要总结
The aim of this randomized controlled trial is to compare the efficacy of vaginal ring pessaries and continence pessaries in the management of patients with both pelvic organ prolapse and stress urinary incontinence, based on the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ), and subjective improvement of symptoms.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- Male
入选标准
- •Patients aged 18 or above;
- •Patients with pelvic organ prolapse according to Pelvic Organ Prolapse Quantification (POP-Q) assessment, and with stress urinary incontinence symptoms;
- •Patients who are willing to give written consent to participate in the study.
排除标准
- •Patients who had history of continence operations;
- •Patients who have conditions contraindicated to use vaginal pessary, such as silicone allergy and presence of vaginal ulcers;
- •Patients unwilling to try pessary treatment;
- •Patients who are planning for pregnancy, or mental incapacity;
- •Patients who cannot understand written Chinese;
- •Patients refuse to participate in the study.
研究组 & 干预措施
Group 1
vaginal ring pessaries
Group 2
ring pessary with knob group (continence pessary)
结局指标
主要结局
Reduction in the PFDI Urinary Distress Inventory scores between both groups at 6 months and 12 months after treatment
次要结局
- 1. Improvements of stress urinary incontinence using the Visual Analog Scale
- 2. Patients’ satisfaction on the vaginal pessaries using the Visual Analog Scale
- 3. Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups
- 4. Changes in other domains of PFDI and PFIQ
- 5. Complications arising from vaginal pessaries
研究者
研究点 (2)
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