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NCT06644261 · ClinicalTrials.gov registry record · Phase 4
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
A Phase 4 study of Chronic Pelvic Pain Syndrome and Pudendal Neuralgia, sponsored by University of Louisville.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06644261: Recruiting Phase 4 study of Chronic Pelvic Pain Syndrome and Pudendal Neuralgia, sponsored by University of Louisville.
NCT06644261 is a Phase 4 study of Chronic Pelvic Pain Syndrome and Pudendal Neuralgia that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 40 participants, below the 193-participant average among 11 other Chronic Pelvic Pain Syndrome trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06644261, a Phase 4 study of Chronic Pelvic Pain Syndrome and Pudendal Neuralgia, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities. The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.
Primary Outcome
VAS will be obtained at baseline, post-procedure, weekly until 6 weeks, scale is 0-100 mm with higher scores indicated more pain severity
Conditions Studied
Interventions
- DRUG Bupivacaine injection
Study Locations (1)
Kentucky
- University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 4 |
What NCT06644261 shows while recruiting
NCT06644261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 193-participant average among 11 other Chronic Pelvic Pain Syndrome trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Chronic Pelvic Pain Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Bupivacaine injection is the first listed.
NCT06644261 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT06644261 about?
NCT06644261 is a clinical study titled "Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia". Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. T...
What is the current status of trial NCT06644261?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-06-27. Estimated completion is 2029-07-01.
What conditions does trial NCT06644261 study?
This clinical trial studies the following conditions: Chronic Pelvic Pain Syndrome, Pudendal Neuralgia.
What interventions are being tested in trial NCT06644261?
The interventions under investigation include: Bupivacaine injection (DRUG).
Who is sponsoring clinical trial NCT06644261?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06644261 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pelvic Pain Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06644261's enrollment target sits among peer trials
40 9th of 11 higher than 2 of 11 other Chronic Pelvic Pain Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pelvic Pain Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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