NCT05585450招募中不适用
Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2023年3月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
研究概览
简要总结
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
- •Male participants aged between 40 and 80 years;
- •Lower urinary tract symptoms (LUTS) for at least three months;
- •IPSS total score ≥8;
- •Prostate volume ≥20 mL;
- •Urinary peak flow rate (Qmax) ≤15 mL/s;
- •Voluntary participation in the trial and signed written informed content.
排除标准
- •Post-void residual urine volume (PVR) ≥150 mL;
- •Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
- •Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
- •Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.);
- •Previous acupuncture treatment for BPH in the preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
- •Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
- •Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.
结局指标
主要结局
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
时间窗: week 20
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
次要结局
- The change from baseline in the total score of IPSS(weeks 4, 8, 12, 20, 32)
- The proportion of participants with at least 30% reduction in the total score of IPSS from baseline(weeks 4, 12, 32)
- The proportion of participants with at least 50% reduction in the total score of IPSS from baseline(weeks 4, 8, 12, 20, 32)
- The change from baseline in the voiding and storage subscale scores of IPSS(weeks 4, 8, 12, 20, 32)
- The change from baseline in the quality of life (QOL) item of IPSS(weeks 4, 8, 12, 20, 32)
- The change from baseline in the BPH Impact Index (BPH-II)(weeks 4, 8, 12, 20, 32)
- The change from baseline in the International Index of Erectile Function 5 (IIEF-5)(weeks 8, 20, 32)
- The change from baseline in the hours of undisturbed sleep (HUS)(weeks 4, 8, 12, 20, 32)
- The change from baseline in the number of nocturia(weeks 4, 8, 12, 20, 32)
- The change from baseline in the Hospital Anxiety and Depression Scale (HADS)(weeks 8, 20, 32)
- The change from baseline in the volume of prostate(week 8)
- The change from baseline in the post-void residual urine volume(week 8)
- The change from baseline in the urinary peak and average flow rate(week 8)
- The proportion of responders per the Patient Global Index of Improvement (PGI-I)(weeks 8, 20, 32)
研究者
Liu Zhishun
Chief Physician, Dean of Acupuncture Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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