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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03720951
Other study ID # Radio frequency prostatitis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date April 2019

Study information

Verified date December 2018
Source Assiut University
Contact ghada Abo Elfadl, M.D
Phone 01005802086
Email ghadafadl77@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Radiation:
pudendal nerve
Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
sacral n roots
Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance

Locations

Country Name City State
Egypt Assiut governorate Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

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

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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