跳至主要内容
临床试验/NCT03720951
NCT03720951Unknown不适用

Comparison Between Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in the Improvement of Pain and Symptoms in Chronic Prostatitis, A Prospective Randomized Study

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Visual Analogue Score

研究概览

简要总结

Prevalence estimates show that prostatitis is one of the most common urological conditions and that symptoms range considerably among men of various socioeconomic status, race, and age. For men under 50 years, prostatitis is the most common urologic outpatient diagnosis. Chronic prostatitis/chronic pelvic pain syndrome has high prevalence estimates internationally ( 16% North America, 14% Asian & Europeans). Men suffering from Chronic prostatitis/chronic pelvic pain syndrome report significant impairment in their quality of life which is also associated with greater health care expenditures.

详细描述

The hallmark indicator of Chronic prostatitis/chronic pelvic pain syndrome has been identified as enduring pain in the perineum, pelvic area, and/or genitalia in many studies. As in other painful chronic conditions, pain does not correspond strongly with objective medical findings and has no orthodox pathology. It is however associated with voiding and sexual disturbances. Symptoms should have been present for at least 3 months within the previous 6 months and must be validated with the standard questionnaire of the National Institute of Health-Chronic Prostatitis Symptom Index. In most patients, pain is the main symptom. Chronic bacterial prostatitis the predominant type of prostatitis is a common and painful condition, typified by pelvic area pain and lower urinary tract symptoms, for which effective diagnostic techniques and treatment strategies remain elusive. Previous studies have documented an association between prostatitis and both psychiatric and rheumatologic diseases. Socioeconomic status indicators, such as lower education and lower income, also played an important role in predicting which men would have worse chronic prostatitis symptoms. These findings are consistent with those found among women with interstitial cystitis; women with lower education and income in the Interstitial Cystitis Database were more likely to report more severe symptoms.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • ASA physical status I-III.

排除标准

  • those with infection at the site of injection,
  • coagulopathy or another bleeding diathesis,
  • a pre-existing neurologic deficit in the targeted region,

研究组 & 干预措施

Group I(Pudendal n.)

Experimental

Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance

干预措施: pudendal nerve (Radiation)

Group II(Sacral n.)

Experimental

Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance

干预措施: sacral n roots (Radiation)

结局指标

主要结局

Visual Analogue Score

时间窗: after 1 month of the intervention

Visual Analogue Score for pain rating( 0 = no pain(minimum) and 10 = the most severe pain(maximum)) will be assessed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Mohammed AboelFadl

principal investigator

Assiut University

研究点 (1)

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