Actively Recruiting
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial
Led by University of Louisville · Updated on 2024-12-18
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic pelvic pain caused by pudendal neuralgia, which involves nerve entrapment or neuropathy of the pudendal nerve, can greatly affect quality of life and lead to increased healthcare costs. This research aims to compare two methods of pudendal nerve block—a transvaginal finger-guided approach and a fluoroscopy-guided trans gluteal approach—to see which provides better pain relief for women suffering from this condition. This is a prospective, randomized controlled trial designed to determine if the less invasive finger-guided method is not inferior to the imaging-guided technique. Participants will be assigned randomly to one of two treatment groups. One group will receive three bilateral injections of 10 mL bupivacaine via the transvaginal approach every two weeks over six weeks. The other group will receive a single bilateral injection of 5 mL bupivacaine guided by fluoroscopy over the same six-week period. After the six-week follow-up, participants may choose to switch to the other treatment if they wish. During the study, researchers will measure changes in pain using the Visual Analog Scale (VAS) at six weeks, along with other validated questionnaires assessing pain intensity, emotional impact, and patient satisfaction. They will also monitor adverse events, time to peak pain relief, and duration of pain relief after injection. The study includes baseline assessments of demographics and pain levels, and participants will be followed closely during the treatment period to track outcomes and safety.
CONDITIONS
Brief Title
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Able to speak and read English
- Diagnosis of pudendal neuralgia or chronic pelvic pain with pain in pudendal nerve area for 3 months or longer
- Minimum pain or bother score of 4 out of 10
- Desire to receive pudendal nerve block treatment
You will not qualify if you...
- Contraindications to pudendal nerve block (such as skin or vaginal infection, allergy to bupivacaine, or uncorrected bleeding problems)
- Pregnant or planning to become pregnant during the study
- Pudendal nerve block received within the last 3 months
- Major pelvic surgery within the last 3 months (such as hysterectomy, prolapse repair, or midurethral sling)
- Neurologic disease affecting the perineum (such as spinal cord injury or multiple sclerosis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive pudendal nerve block injections to relieve chronic pelvic pain. One group receives injections via a transvaginal approach every 2 weeks for a total of 3 injections over 6 weeks. Another group receives one fluoroscopy-guided trans gluteal injection during the 6-week period.
3 visits for transvaginal injections every 2 weeks or 1 visit for fluoroscopy-guided injection over 6 weeks
Duration - Not specified
After completing the 6-week treatment, participants have the option to crossover to the alternative treatment arm for additional evaluation of pain relief.
Visits as needed for crossover treatment
Trial Site Locations
Total: 1 location
1
University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
L
Laurel Carbone, MD
S
Sean Francis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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