Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

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

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.

Study Overview

• Status: Completed
• Conditions: Superficial Dyspareunia
• Intervention / Treatment: Procedure: pudendal nerve pulsed radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 0020
    • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: trans-gluteal approach; received pudendal nerve pulsed radiofrequency through trans-gluteal approach	Procedure: pudendal nerve pulsed radiofrequency; received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
Active Comparator: trans-vaginal approach; received pudendal nerve pulsed radiofrequency through trans-vaginal approach	Procedure: pudendal nerve pulsed radiofrequency; received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Numerical rating scale	0 no pain and 10 maximum pain	baseline reading -1 day reading-3 days postoperative reading

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: Alaa Elzohry, MD, South Egypt Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia
• Other Study ID Numbers: PNB

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