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

NCT ID: NCT03720951

Last Updated: 2018-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-04-30

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.

Conditions

Prostatitis; Pulsed Radiofrequency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I(Pudendal n.)

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

Group Type: EXPERIMENTAL

pudendal nerve

Intervention Type: RADIATION

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

Group II(Sacral n.)

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

Group Type: EXPERIMENTAL

sacral n roots

Intervention Type: RADIATION

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

Interventions

pudendal nerve

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

Intervention Type: RADIATION

sacral n roots

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

Intervention Type: RADIATION

Eligibility Criteria

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,

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ghada Abo Elfadl, M.D

Role: CONTACT

ghadafadl77@gmail.com

01005802086

Facility Contacts

Ghada M Aboelfadl, MD

Role: primary

ghadafadl77@gmail.com

01005802086

References

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.

Reference Type: BACKGROUND

PMID: 17014600 (View on PubMed)

Issa W, Roumeguere Te, Bossche MV. [Chronic pelvic pain syndrome]. Rev Med Brux. 2013 Jan-Feb;34(1):29-37. French.

Reference Type: BACKGROUND

PMID: 23534312 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24080807 (View on PubMed)

Other Identifiers

Radio frequency prostatitis

Identifier Type: -

Identifier Source: org_study_id