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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 11, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2020
CompletedApril 9, 2020
April 1, 2020
1.3 years
December 11, 2019
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in Numerical rating scale
0 no pain and 10 maximum pain
baseline reading -1 day reading-3 days postoperative reading
Study Arms (2)
trans-gluteal approach
ACTIVE COMPARATORreceived pudendal nerve pulsed radiofrequency through trans-gluteal approach
trans-vaginal approach
ACTIVE COMPARATORreceived pudendal nerve pulsed radiofrequency through trans-vaginal approach
Interventions
received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
Eligibility Criteria
You may qualify if:
- women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa Elzohry, MD
South Egypt Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 11, 2019
First Posted
December 16, 2019
Study Start
December 1, 2018
Primary Completion
March 20, 2020
Study Completion
March 25, 2020
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share