Comparing two methods for pudendal nerve block in pelvic pain treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy of two different approaches for administering a pudendal nerve block in women suffering from pudendal neuralgia or chronic pelvic pain. Participants will be randomized to receive either a transvaginal pudendal nerve block without imaging or a fluoroscopy-guided trans gluteal pudendal nerve block. The primary outcome will be measured by changes in pain levels using the Visual Analog Scale over a six-week period. Secondary objectives include assessing patient satisfaction and the emotional impact of pain through validated questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* women \>18 years
* English speaking/reading
* Diagnosis of pudendal neuralgia OR chronic pelvic pain with pain in the distribution of the pudendal nerve for 3 months or longer
* Minimum pain/bother score of 4/10
* Desire for pudendal nerve block

Exclusion Criteria:

* Contraindication to pudendal nerve block (examples: skin or vaginal infection, bupivacaine allergy, uncorrected coagulopathy)
* Pregnant or intending to become pregnant during the study
* Pudendal nerve block from any route within the last 3 months
* Major pelvic surgery within the last 3 months (examples: hysterectomy, prolapse repair, midurethral sling)
* Neurologic disease affecting the perineum (examples: spinal cord injury, multiple sclerosis)

Where it's running

• University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Laurel Carbone, MD
• Email: laurel.carbone@louisville.edu
• Phone: 502-588-7660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.