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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostatitis; Pulsed Radiofrequency
• Intervention / Treatment: Radiation: pudendal nerve; Radiation: sacral n roots

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ghada Abo Elfadl, M.D; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut governorate
    • Contact: Ghada M Aboelfadl, MD; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Cahana A, Van Zundert J, Macrea L, van Kleef M, Sluijter M. Pulsed radiofrequency: current clinical and biological literature available. Pain Med. 2006 Sep-Oct;7(5):411-23. doi: 10.1111/j.1526-4637.2006.00148.x.
• Issa W, Roumeguere Te, Bossche MV. [Chronic pelvic pain syndrome]. Rev Med Brux. 2013 Jan-Feb;34(1):29-37. French.
• Pontari M, Giusto L. New developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome. Curr Opin Urol. 2013 Nov;23(6):565-9. doi: 10.1097/MOU.0b013e3283656a55.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pulsed Radiofrequency; chronic Prostatitis
• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis
• Other Study ID Numbers: Radio frequency prostatitis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No