Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostatitis, Pulsed Radiofrequency

Intervention / Treatment
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* Radiation: pudendal nerve
* Radiation: sacral n roots


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-III. Exclusion Criteria: those with infection at the site of injection, coagulopathy or another bleeding diathesis, a pre-existing neurologic deficit in the targeted region,

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I(Pudendal n.)<br>Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance | Radiation: pudendal nerve<br>* Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance<br>|
| Experimental: Group II(Sacral n.)<br>Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance | Radiation: sacral n roots<br>* Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score | Visual Analogue Score for pain rating( 0 = no pain(minimum) and 10 = the most severe pain(maximum)) will be assessed | after 1 month of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed Radiofrequency, chronic Prostatitis