Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
研究概览
简要总结
To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;
- •NIH-CPSI score > 10;
- •The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;
- •Age ≥18 years old and ≤60 years old agrees and signs the informed consent;
- •Those who did not receive other similar treatment regimens during treatment.
排除标准
- •All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;
- •Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;
- •For patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.;
- •Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;
- •People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.
- •People who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.
研究组 & 干预措施
Electrophysiological treatment group
Two electrodes covered the two acupoints of Zhongliao and Huiyang, one electrode covered the three acupoints of Zhongji, Guanyuan and Qihai, and two skin paste electrodes covered the three acupoints of Sanyinjiao, and connected the electric stimulation therapy instrument for 30 minutes. The intensity was based on the patient's tolerance. 4 weeks before the course of treatment, the treatment was performed once a day, 3 times a week.In the last 4 weeks, 20 times were performed twice a week.Fluoroquinolones and alpha blockers were administered according to the patient's symptoms.
干预措施: Percutaneous electrical nerve stimulation treatment (Drug)
结局指标
主要结局
National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
时间窗: through study completion, an average of 1 year
Improvement rate = \[(score before treatment - score at the end of treatment)/score before treatment\] ×100% The improvement rate ≥75% was considered to be significant.The improvement rate \< 75% and ≥50% were considered to be better. The improvement rate \< 50% and ≥25% were considered as average efficacy.The improvement rate \< 25% indicates poor efficacy.
次要结局
- international prostate symptom score (IPSS)(through study completion, an average of 1 year)
研究者
Yuan Jianlin-1
professor
Xijing Hospital