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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

NCT ID: NCT03720951

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Prostatitis Pulsed Radiofrequency

Keywords

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Pulsed Radiofrequency chronic Prostatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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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

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ghada Abo Elfadl, M.D

Role: CONTACT

Phone: 01005802086

Email: [email protected]

Facility Contacts

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Ghada M Aboelfadl, MD

Role: primary

References

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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

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Radio frequency prostatitis

Identifier Type: -

Identifier Source: org_study_id