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Status unknownNCT03720951Updated Dec 19, 2018

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

An interventional study of pudendal nerve and sacral n roots in Prostatitis and Pulsed Radiofrequency, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to male participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostatitis
  • Pulsed Radiofrequency

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Keywords

  • Pulsed Radiofrequency
  • chronic Prostatitis
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In context

Prostatitis

83 studies on the registry are indexed under Prostatitis; 9 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 66 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • ASA physical status I-III.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group I(Pudendal n.)

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

    Radiation: pudendal nerve

  • Experimental
    Group II(Sacral n.)

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

    Radiation: sacral n roots

Interventions

  • Radiationpudendal nerve

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

  • Radiationsacral n roots

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

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What researchers measure

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

    Time frame: after 1 month of the intervention

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Study locations

1 of 1 sites recruiting
  • Assiut governorate
    Assiut, Egypt
    Recruiting
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References and documents

Publications

  • 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. PubMed 17014600 ↗
  • Issa W, Roumeguere Te, Bossche MV. [Chronic pelvic pain syndrome]. Rev Med Brux. 2013 Jan-Feb;34(1):29-37. French. PubMed 23534312 ↗
  • 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. PubMed 24080807 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03720951
Lead sponsor
Assiut University
Responsible party
Ghada Mohammed AboelFadl (principal investigator, Assiut University) — Principal investigator
First posted
Oct 26, 2018
Start date
Nov 1, 2018
Primary completion
Mar 2019 (estimated)
Completion
Apr 2019 (estimated)
Last update
Dec 19, 2018

Study contacts

ghada Abo Elfadl, M.D
Contact
ghadafadl77@gmail.com
01005802086

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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