NCT00260637已完成2 期
A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- Six point drop in NIH-CPSI total Score
研究概览
简要总结
Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.
详细描述
Various studies have reported that this acupuncture able to relieve symptoms of chronic prostatitis (CP)/ chronic pelvic pain syndrome (CPPS). However, controversy exists on the efficacy of this technique due to poor experimental designs and lack of placebo controls in these experiment. This study is the first randomised controlled study which will evaluate if acupuncture for 10 weeks will help improve symptoms of CP/CPPS
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
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Symptoms of discomfort or pain in the pelvic region for at least a three (3) months period within the last six (6) months.
- •Moderate overall score on the NIH-CPSI (overall score more than 15 out of a potential of 0-43 points)
- •Diagnosed as having CPPS Category III
- •Participant is willing to undergo 10 weeks of acupuncture treatment
排除标准
- •History of prostate, bladder or urethral cancer.
- •Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
- •Undergone pelvic radiation or systemic chemotherapy, intravesical chemotherapy or intravesical BCG.
- •Treated for unilateral orchialgia without pelvic symptoms.
- •Active urethral stricture.
- •Undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
- •Neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- •Liver disease.
- •Diagnosed as acute or chronic bacterial prostatitis.
- •History of urinary tract infection positive uropathogen for the past year.
- •Taking medications which could affect the lower urinary tract function
- •History of type 1 or 2 diabetes.
- •Treated/currently undergoing treatment with acupuncture for any other illness including prostatitis for the past 6 months.
- •Refusal to be needled or any form of bleeding disorder.
结局指标
主要结局
Six point drop in NIH-CPSI total Score
次要结局
- Individual domains of the NIH-CPSI
- Patient reported Global Response Assessment
- International Prostate Symptom Score
- International Index of Erectile Function
- Brief Pain Inventory- Short Form
研究者
研究点 (8)
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