Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03884764 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : September 16, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Pain | Procedure: pulsed radiofrequency Procedure: ganglion impar denervation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | November 30, 2020 |
Estimated Study Completion Date : | December 15, 2020 |
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 |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884764
Egypt | |
Diab | Recruiting |
Assiut, Assuit, Egypt, 71515 | |
Contact: Diab Hetta, MD +201091090009 diabgetta25@gmail.com |
Responsible Party: | Diab Fuad Hetta, principle investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT03884764 |
Other Study ID Numbers: |
SECI-IRB-IORG0009563-724 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | September 16, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Pain Pain Neurologic Manifestations |