Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

Superficial Dyspareunia Clinical Trial

Official title:

Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201041
• Other study ID #: PNB
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: March 25, 2020

Study information

• Verified date: April 2020
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 25, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 46 Years

Eligibility

Inclusion Criteria:

• women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up

Exclusion Criteria:

• We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study

Related Conditions & MeSH terms

• Dyspareunia
• Superficial Dyspareunia

Intervention

Procedure:
• pudendal nerve pulsed radiofrequency
received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Numerical rating scale	0 no pain and 10 maximum pain	baseline reading -1 day reading-3 days postoperative reading