Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain

September 12, 2020 updated by: Diab Fuad Hetta, Assiut University

for Patients With Chronic Pelvic Pain Due to Chronic Prostatitis, do Combined Ganglion Impar Denervation and Pulsed Radiofrequency on Sacral Root 3 Acheive Better Analgesia Than Ganglion Impar Alone

the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71515
        • Recruiting
        • Diab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
  • VAS pain score more than 5
  • failed analgesic drug treatment

Exclusion Criteria:

  • coagulopathy
  • neurogenic bladder
  • infection at site of procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF on S3 + ganglion impar denervation
patients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol
Procedure: pulsed radiofrequency
patients with chronic pelvic pain due to chronic prostatitis will receive pulsed radiofrequency on sacral root number 3 and ganglion impar denervation and the patients will be followed for 6 months to assess pain severity radiofrequency procedure: patients will positioned prone on the operating table and under x-ray guidence sacral foramen number 3 will be identified and through it radiofrequency needle will be advanced to target the sacral root ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
Active Comparator: ganglion impar denervation
patients will receive ganglion impar denervation by alcohol
Procedure: ganglion impar denervation
patients with chronic pelvic pain due to chronic prostatitis will receive ganglion impar denervationand and the patients will be followed for 6 months to assess pain severity ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score
Time Frame: patients will be evaluated at 3 months postoperatively
VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable
patients will be evaluated at 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECI-IRB-IORG0009563-724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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