Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 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
Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.
We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •symptomatic >3 months
- •NIH-CPSI total score =/>15
- •NIH-CPSI pain =/>8
排除标准
- •post void residual >100mL
- •urinary tract infection
- •urethral stricture
- •prostate cancer
- •age <18 years
- •claustrophobia
- •pacemaker, neurostimulator, insulin / pain pump
研究组 & 干预措施
1
Combined sono-electro-magnetic therapy
干预措施: combined sono-electro-magnetic therapy (Sonodyn Medico Star) (Device)
2
placebo therapy
干预措施: placebo therapy (Placebo Sonodyn Medico Star) (Device)
结局指标
主要结局
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
时间窗: before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment
次要结局
- Brain activity assessed by functional MRI(before treatment, after 12 weeks of treatment)
- Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database(before treatment)