ITMCTR2100004306招募中未知
Acupuncture for Urinary Incontinence in Patients With Prostate Cancer Surgery: a Multicenter, Single-Blinded, Randomized, Parallel-Controlled Trial
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- Male
入选标准
- •1. Meet the diagnostic criteria for prostate cancer;
- •2. Meet the diagnostic criteria for urinary incontinence (1), (2), (3), (4);
- •3. Karnofsky score >= 60 points or ECOG 0-1 points;
- •4. Aged >= 18 years;
- •5. Sign informed consent.
排除标准
- •1.Urgent urinary incontinence caused by detrusor hyperreflexia and bladder spasm, and urinary incontinence caused by central or endocrine factors;
- •2.Urinary incontinence was treated after cystostomy, reconstruction of urethral sphincter, suspension of urethra and other treatments;
- •3.Receiving treatment methods similar to acupuncture treatment principles (such as electroacupuncture, warm moxibustion, warm acupuncture, etc.) at present or within six months;
- •4.Complete urinary incontinence after prostate cancer surgery, that is, surgery to damage the pudendal nerve, complete loss of external urethral sphincter function through urodynamic test;
- •5.People with urinary tract infection (except those with asymptomatic lower urinary tract infection);
- •6.Known severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, heart failure and other serious heart diseases;
- •7.Known liver injury or potentially serious liver disease (ALT or AST > 10 times normal);
- •8.Known severe renal function impairment (eGFR < 25mL/min/1.73m2), or planned or in dialysis, or acute contrast nephropathy at the time of screening;
- •9.Known other important organ dysfunction or severe primary diseases such as hematopoietic system;
- •10.Known coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results);
- •11.Patients with mental illness or cognitive impairment, severe depression, alcohol dependence and drug abuse history;
- •12.In addition to prostate cancer surgery, patients with urinary incontinence due to other reasons;
- •13.According to the judgment of the researcher, those who are not suitable to participate in this research, or have factors that are likely to fall out of the group, such as frequent changes in the work environment, which may easily cause loss to follow-up;
- •14.According to the researcher's judgment, the survival period may be <= 6 months;
- •15.Participating in other clinical trials.
研究者
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