Back to resultsPudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
Primary Purpose
Superficial Dyspareunia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pudendal nerve pulsed radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Dyspareunia
Eligibility Criteria
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
Sites / Locations
- South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
trans-gluteal approach
trans-vaginal approach
Arm Description
received pudendal nerve pulsed radiofrequency through trans-gluteal approach
received pudendal nerve pulsed radiofrequency through trans-vaginal approach
Outcomes
Primary Outcome Measures
change in Numerical rating scale
0 no pain and 10 maximum pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04201041
First Posted
December 11, 2019
Last Updated
April 7, 2020
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04201041
Brief Title
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
Official Title
Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Dyspareunia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trans-gluteal approach
Arm Type
Active Comparator
Arm Description
received pudendal nerve pulsed radiofrequency through trans-gluteal approach
Arm Title
trans-vaginal approach
Arm Type
Active Comparator
Arm Description
received pudendal nerve pulsed radiofrequency through trans-vaginal approach
Intervention Type
Procedure
Intervention Name(s)
pudendal nerve pulsed radiofrequency
Intervention Description
received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
Primary Outcome Measure Information:
Title
change in Numerical rating scale
Description
0 no pain and 10 maximum pain
Time Frame
baseline reading -1 day reading-3 days postoperative reading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Elzohry, MD
Organizational Affiliation
South Egypt Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
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