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

NCT ID: NCT03884764

Last Updated: 2020-09-16

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

2019-04-01

Study Completion Date

2020-12-15

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRF on S3 + ganglion impar denervation

patients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol

Group Type EXPERIMENTAL

pulsed radiofrequency

Intervention Type PROCEDURE

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

ganglion impar denervation

patients will receive ganglion impar denervation by alcohol

Group Type ACTIVE_COMPARATOR

ganglion impar denervation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 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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Diab Fuad Hetta

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diab

Asyut, Assuit, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Diab Hetta, MD

Role: primary

+201091090009

Other Identifiers

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SECI-IRB-IORG0009563-724

Identifier Type: -

Identifier Source: org_study_id

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