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

A

Assiut University

Status

Unknown

Conditions

Prostatitis
Pulsed Radiofrequency

Treatments

Radiation: pudendal nerve
Radiation: sacral n roots

Study type

Interventional

Funder types

Other

Identifiers

NCT03720951
Radio frequency prostatitis

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

ghada Abo Elfadl, M.D

Data sourced from clinicaltrials.gov

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