Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

Not Applicable

Completed

• Conditions: Superficial Dyspareunia
• Interventions: Procedure: pudendal nerve pulsed radiofrequency

• Registration Number: NCT04201041
• Lead Sponsor: South Egypt Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trans-gluteal approach	pudendal nerve pulsed radiofrequency	received pudendal nerve pulsed radiofrequency through trans-gluteal approach
trans-vaginal approach	pudendal nerve pulsed radiofrequency	received pudendal nerve pulsed radiofrequency through trans-vaginal approach

Primary Outcome Measures

Name	Time	Method
change in Numerical rating scale	baseline reading -1 day reading-3 days postoperative reading	0 no pain and 10 maximum pain

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt; 🇪🇬 Assiut, Egypt