Effectiveness 0f Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit
研究概览
简要总结
The purpose of this study is to investigate, by means of a temporary sympathetic nerve block, the involvement of the sympathetic nervous system in Chronic Pelvic Pain Syndrome (CPPS). This study may also result in a new therapeutic approach for male CPPS.
详细描述
Male pelvic pain is a common urological complaint. Oftentimes patients are given the diagnosis of chronic prostatitis. Although the term "chronic prostatitis" is commonly associated with infection, less than 5% of men presenting with pelvic pain are found to have evidence of urogenital infection with common pathogens. Because no etiology can usually be associated with the pain, chronic idiopathic prostatitis is now called male chronic pelvic pain syndrome (CPPS). Options proposed for the treatment of male CPPS have had limited and variable success rates.
Although several abnormalities of the nervous system have been proposed as possible causes of CPPS, the clinical nature of the disease suggests involvement of the sympathetic nervous system. The sympathetic nervous system may be involved in many regional pain syndromes, and in such situations, the term "sympathetically maintained pain" has been used with complex regional pain syndromes. Block of the sympathetic nerves supplying this region is commonly used to detect sympathetic nervous system involvement.
Sympathetic nerve blocks have been used in some clinical studies involving pelvic pain but most of these studies included cancer patients with pelvic pain. The type of sympathetic blocks used for pelvic pain is superior hypogastric plexus block and it involves instillation of neural blocking agents such as local anesthetic agents in the region of the plexus, usually under fluoroscopic control. Nociceptive afferent transmission from pelvic viscera is probably via the superior hypogastric plexus. This treatment option has not been systematically used for male CPPS.
In this study, a temporary block of the superior hypogastric plexus with bupivacaine will be used to assess the degree of sympathetic block with some electrodiagnostic tests. After the temporary nerve block, the analgesic efficacy will be monitored. Therefore, in this study, we hope not only to explain the sympathetic nature of the disease in more concrete terms but also propose a new therapeutic approach for male CPPS.
Men with a diagnosis of non-bacterial chronic pelvic pain who have not responded to treatment will be asked to participate in this study. The subjects will be randomly assigned to receive either active medication as the sympathetic plexus block or placebo. All other study elements will be identical for both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with Chronic Pelvic Pain Syndrome who, for the past year, have not responded to standard pain treatment modalities.
排除标准
- •Urinary tract infection with common pathogens
- •Treatment for prostate, bladder, renal, or other urinary malignancies.
- •Back pain or rectal pain only
- •Psychotic or suicidal men
- •Post-surgical pain
- •Pain from another source in genital the tract such as kidney stones or neoplasm
- •Having had radiation therapy
- •History of genitourinary tuberculosis
- •Neurological abnormalities such as stroke, brain tumors, spinal tumors, spinal cord injury and Parkinson's or Alzheimer's disease.
- •Drug allergies
- •Use of any drugs, such as antihypertensives, that would interfere with biochemical and electrodiagnostic tests.
- •Bleeding and clotting disorders such as factor deficiencies or anticoagulant drug use.
结局指标
主要结局
change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit
次要结局
- AUA score at Block Assessment Visit
