Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis
Primary Purpose
Prostatitis, Pulsed Radiofrequency
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pudendal nerve
sacral n roots
Sponsored by
About this trial
This is an interventional treatment trial for Prostatitis focused on measuring Pulsed Radiofrequency, chronic Prostatitis
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,
Sites / Locations
- Assiut governorateRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I(Pudendal n.)
Group II(Sacral n.)
Arm Description
Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance
Outcomes
Primary Outcome Measures
Visual Analogue Score
Visual Analogue Score for pain rating( 0 = no pain(minimum) and 10 = the most severe pain(maximum)) will be assessed
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03720951
Brief Title
Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis
Official Title
Comparison Between Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in the Improvement of Pain and Symptoms in Chronic Prostatitis, A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis, Pulsed Radiofrequency
Keywords
Pulsed Radiofrequency, chronic Prostatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I(Pudendal n.)
Arm Type
Experimental
Arm Description
Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
Arm Title
Group II(Sacral n.)
Arm Type
Experimental
Arm Description
Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance
Intervention Type
Radiation
Intervention Name(s)
pudendal nerve
Intervention Description
Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
Intervention Type
Radiation
Intervention Name(s)
sacral n roots
Intervention Description
Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance
Primary Outcome Measure Information:
Title
Visual Analogue Score
Description
Visual Analogue Score for pain rating( 0 = no pain(minimum) and 10 = the most severe pain(maximum)) will be assessed
Time Frame
after 1 month of the intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ghada Abo Elfadl, M.D
Phone
01005802086
Email
ghadafadl77@gmail.com
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada M Aboelfadl, MD
Phone
01005802086
Email
ghadafadl77@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
17014600
Citation
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.
Results Reference
background
PubMed Identifier
23534312
Citation
Issa W, Roumeguere Te, Bossche MV. [Chronic pelvic pain syndrome]. Rev Med Brux. 2013 Jan-Feb;34(1):29-37. French.
Results Reference
background
PubMed Identifier
24080807
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.
Results Reference
background
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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
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