Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia.
研究概览
简要总结
- This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence.
- LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.
详细描述
Collect 120 women(A. Overactive bladder、B. Stress incontinence、C. Interstitial cystitis D. Female sexual dysfunction), Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. PRP treatment at 1, 5, 9 weeks), and to complete all treatment after 4 weeks and 24 weeks back to the clinic, evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI)、Urinary tract dynamics test、Urination log、Cotton pad test、Blood test(ESR、CA125、CBC、CRP). ○DLow Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 4 weeks, and to complete all treatment 4th and after 4 weeks back to the clinic, Pelvic Doppler ultrasound ,evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •One of the following symptoms can be included:
- •Overactive bladder
- •Stress incontinence
- •Interstitial cystitis
- •Not Menopause and female sexual dysfunction (FSFI scores< 26)
- •The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.
- •Women over 20 years.
排除标准
- •No UTI during the past week.
- •Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease.
- •urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome).
- •Patients with acute or chronic infectious diseases.
- •Patients with acute or chronic cardiovascular disease.
- •Patients with a history of chronic liver and kidney disease.
- •Patients receiving anticoagulant therapy(Aspirin and NSAIDs COX-1).
- •Patients with bleeding disorders.
- •Receive low energy extracorporeal shock wave treatment within 1 month before entering the trial.
- •Urinary incontinence need to install the catheter.
- •Pregnant women.
- •Unable to sign the consent form.
结局指标
主要结局
Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia.
时间窗: 8 months
1.Questionnaire assessment before and after treatment (OABSS, UDI-6, IIQ-7, ICIQ-SF, POPDI-6, FSFI) . 2.urodynamic examination before and after treatment
Assess the patient for changes in lower abdominal pain
时间窗: 8 months
VAS pain index record before and after treatment
次要结局
- Promote the repair and proliferation of blood vessels in the vulva to improve sexual function and improve the overall quality of sexual life.(2 months)