The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The score of ICI-Q-SF
研究概览
简要总结
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail
详细描述
- Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence
- Study design: This is a randomized, double-blind, controlled, multi-center clinical trial
- Study subjects: Females with mild to moderate stress urinary incontinence
- Number of subjects: 60
- Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University
- Treatment methods:
Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as mild to moderate female stress urinary incontinence in our hospital;
- •other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being;
- •volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form.
排除标准
- •other types of urinary incontinence;
- •blood routines indicate acute and chronic blood system diseases;
- •B-ultrasound suggests other gynecological diseases;
- •combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases;
- •previous or current history of pelvic surgery and radiotherapy and chemotherapy;
- •the investigator determined that it is not suitable for this clinical trial.
研究组 & 干预措施
Test Group
After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks.
干预措施: LIPUS-1 (Device)
Control Group
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
干预措施: LIPUS-2 (Device)
结局指标
主要结局
The score of ICI-Q-SF
时间窗: change from baseline level at 2 months after treatment
measure the international committee of incontinence brief list of urinary incontinence by a questionnaire
次要结局
未报告次要终点