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

NCT03720951 | Unknown

• 1 other identifier: Radio frequency prostatitis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatitis; Pulsed Radiofrequency

Keywords

Pulsed Radiofrequency; chronic Prostatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I(Pudendal n.)

EXPERIMENTAL

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

Radiation: pudendal nerve

Group II(Sacral n.)

EXPERIMENTAL

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

Radiation: sacral n roots

Interventions

pudendal nerve RADIATION

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

Group I(Pudendal n.)

sacral n roots RADIATION

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

Group II(Sacral n.)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut governorate

Asyut, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 17014600 BACKGROUND

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

  PMID: 23534312 BACKGROUND

• 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.

  PMID: 24080807 BACKGROUND

MeSH Terms

Conditions

Prostatitis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

ghada Abo Elfadl, M.D

CONTACT

01005802086; ghadafadl77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 26, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

EG (1)