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

Not Applicable

• Conditions: Pulsed Radiofrequency; Prostatitis
• Interventions: Radiation: pudendal nerve; Radiation: sacral n roots

• Registration Number: NCT03720951
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2018-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-16
• Last Update Posted: 2018-12-19
• Primary Completion: 2019-03
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I(Pudendal n.)	pudendal nerve	Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
Group II(Sacral n.)	sacral n roots	Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance

Primary Outcome Measures

Name	Time	Method
Visual Analogue Score	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

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt