Efficacy of Electromagnetic Stimulation Therapy for the Treatment of Chronic Prostatitis or Chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in NIH-CPSI total and pain score
研究概览
简要总结
In 1995 the National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) workshop reached a consensus on the definition and classification of prostatitis syndromes.The commonest and yet most poorly understood of these prostatitis syndromes is category III or chronic pelvic pain syndrome (CPPS). It has been shown that, while men with CPPS have significantly higher leukocyte counts in urine and expressed prostatic secretions compared with age matched controls, inflammation and infection do not necessarily correlate with symptom severity.
The lack of a direct relationship between inflammation and symptoms is supported through studies of prostate histopathology, in which moderate or severe inflammation was identified in only 5% of men with CPPS.Conventional treatment has focused on long, empirical courses of expensive broad-spectrum antibiotics, mostly of the quinolone class, with or without the concomitant use of an α-blocker and anti-inflammatory agents. At the turn of the 19th century stimulation with electrical current and changing magnetic fields was used to treat surface conditions associated with intractable pain, such as painful malignant ulcers. The analgesic benefits of pulsed electromagnetic fields for relieving pelvic pain has been investigated in women with tissue trauma and chronic refractory pelvic pain.Despite its uncertain etiology there is some evidence that the symptom complex found in CPPS may be founded at least in part in pelvic floor muscular dysfunction and/or neurogenic hypersensitivity/inflammation.
We hypothesized that the application of a electromagnetic stimulation to the perineum of the subject may result in neural excitation and pelvic floor muscle stimulation to a degree that breaks the cycle of tonic muscular spasm and neural hypersensitivity/inflammation, thereby, restoring more normal pelvic floor muscular activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •male patients with
- •NIDDK category III chronic prostatitis/chronic pelvic pain syndrome
- •Symptom duration ≥ 3 months
- •The sum of 1 or 2 domain of NIH-CPSI ≥ 1 point
- •The sum NIH-CPSI ≥ 15 points
排除标准
- •patients with
- •History of prostate cancer
- •History of pelvic irradiation
- •History of transurethral surgery
- •Urinary tract infection within 6 months to screening
- •Postvoid urine volume ≥ 150ml
- •Interstitial cystitis
研究组 & 干预措施
Electromagnetic stimulation
Electromagnetic stimulation therapy
干预措施: Electromagnetic Stimulation Therapy (Device)
结局指标
主要结局
Change in NIH-CPSI total and pain score
时间窗: 24 weeks after treatment
次要结局
- Changes in - NIH-CPSI urinary, QoL impact score - Qmax/PVR - frequency/24hrs - urgency episode/24hrs - Patient perception of treatment benefit, satisfaction, willingness to continue - Goal achievement - Patient's Perception of Symptom Improvement(24 weeks of treatment)
