A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Urine leakage in 1-hour pad test
研究概览
简要总结
To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.
详细描述
Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.
排除标准
- •Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.
结局指标
主要结局
Urine leakage in 1-hour pad test
时间窗: before therapy
measure the urine leakage in 1-hour pad test
Change from urine leakage at 3 months
时间窗: 3months after therapy
measure the urine leakage in 1-hour pad test at 3 months
Change from urine leakage at 12 months
时间窗: 12months after therapy
measure the urine leakage in 1-hour pad test at 12 months
次要结局
- incontinence impact questionnaire short form,IIQ-7(12months after therapy)
- pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12(12months after therapy)
- Female Sexual index，FSFI(12months after therapy)
研究者
Li Yan
pfofessor
Qianfoshan Hospital