Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Proportion of Responders at the End of 8-week
研究概览
简要总结
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It affects men of all ages without apparent racial predisposition, among which, 36-50 years old are the most commonly influenced. Yet, few effective therapies are available for treating CP/CPPS.
Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture on CP/CPPS remain uncertain because of the small sample sizes or other methodological limitations.
The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will provide a robust conclusion with a high level of evidence.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1.History of pain perceived in the prostate region and absence of other lower urinary tract pathology for a minimum of three of the past 6 months. In addition, any associated lower urinary tract symptoms, sexual function, and psychological factors should be addressed. Physical examinations, urinary analyses, and urine cultures will be performed for all subjects;
- •Age 18 to 50 years.
- •NIH Chronic Prostatitis Symptom Index (NIH- CPSI) total score ≥ 15.
排除标准
- •Prostate, bladder, or urethral cancer, seizure disorder in any medical history.
- •Inflammatory bowel disease, active urethral stricture, neurologic disease or disorder affecting the bladder, liver disease, neurologic impairment or psychiatric disorder preventing understanding of consent and self-report scale.
- •Urinary tract infection with a urine culture value of more than 100,000 CFU/mL, clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhoea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS), symptoms of acute or chronic epididymitis).
- •Residual urine volume≥100ML.
- •Qmax≤15ML/S.
- •Prior 4 weeks used androgen hormone inhibitors (finasteride), alpha-blockers (terazosin HCI, doxazosin mesylate, tamsulosin hydrochloride), antibiotics (ciprofloxacin hydrochloride), or any other prostatitis-specific medication (including herb and Chinese medicine).
结局指标
主要结局
Proportion of Responders at the End of 8-week
时间窗: week 8
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
Proportion of Responders at the End of 32-week
时间窗: week 32
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.
次要结局
- the Change From Baseline in the International Prostate Symptom Score (IPSS)(week 4; week 8; week 20; week 32)
- the Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire(week 8; week 20; week 32)
- the Change From Baseline in the Hospital Anxiety and Depression Scale (HADS)(week 8; week 20; week 32)
- the Change From Baseline in the International Index of Erectile Function 5 (IIEF-5)(week 8; week 20; week 32)
- the Change for Peak and Average Urinary Flow Rate From Baseline(weeks 8 and 32)
- Proportion of Responders at Other Time Points(weeks 1-7; week 20)
- the Change From Baseline in NIH-CPSI Subscales(weeks 1-8; week 20; week 32)
- the Proportions of Participants in Each Response Category of the Global Response Assessment (GRA)(week 4; week 8; week 20; week 32)
- the Change From Baseline in NIH-CPSI Total Score(weeks 1-8; week 20; week 32)
研究者
Liu Zhishun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences