Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-03-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Superficial Dyspareunia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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trans-gluteal approach

received pudendal nerve pulsed radiofrequency through trans-gluteal approach

Group Type ACTIVE_COMPARATOR

pudendal nerve pulsed radiofrequency

Intervention Type PROCEDURE

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

trans-vaginal approach

received pudendal nerve pulsed radiofrequency through trans-vaginal approach

Group Type ACTIVE_COMPARATOR

pudendal nerve pulsed radiofrequency

Intervention Type PROCEDURE

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

Interventions

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pudendal nerve pulsed radiofrequency

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No