Construction of the Early Warning and Prevention System for Urinary Incontinence in the Elderly--the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence--a Multi-center Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- The difference in the effective rate of urinary incontinence treatment between the two groups
研究概览
简要总结
Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.
详细描述
Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old and above; 2) Have a history of sexual life; 3) Plan to live locally for a long time; 4) Mild to moderate pressure, urgency or mixed urinary incontinence; 5) The patient agrees to conduct the study and signs an informed consent form.
排除标准
- •Combined pelvic organ prolapse (with extrahymen bulging);
- •Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
- •Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
- •Combined connective tissue disease;
- •Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
- •Malignant tumors;
- •Combined neurological diseases (patients with epilepsy and dementia);
- •Those with a synchronized pacemaker on their chest (biofeedback can be done).
结局指标
主要结局
The difference in the effective rate of urinary incontinence treatment between the two groups
时间窗: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not
次要结局
- Person coefficient of correlation between results of gynecological examination and new equipment examination(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in pelvic floor electromyography between the two groups(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in questionnaire score： PFDI-20(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in pelvic floor pressure test between the two groups(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in pelvic floor tension test between the two groups(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in 72-hour urination diary(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in questionnaire score： ICI-Q-SF(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in questionnaire score： OABSS(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
- Differences in questionnaire score： UDI-6(Before treatment, immediately after treatment, three months after treatment, and six months after treatment)
研究者
Sun Xiuli
Chief Gynecology Physician
Peking University People's Hospital