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Lidocaine Patches Prior to Percutaneous Nerve Evaluation
Phase 2 trial testing Lidocaine patch in Overactive Bladder in 39 participants. Completed in 1 April 2024.
| Lead sponsor | University of Louisville |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 1 May 2023 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 April 2024 |
| Sites | 2 locations across United States |
University of Louisville
18 and older, female only, with Overactive Bladder or Urge Incontinence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Visual Analog Scale pain score (indicating the difference between pre and post-procedural pain scores). The scores in question were 100 mm visual analog scale pain scores. This scale ranges from 0-100mm. Higher 100mm Visual Analog Scale pain scores indicate worsening pain.
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 45 | ± 17 |
| Placebo | 61 | ± 21 |
Satisfaction score collected after PNE procedure. This was accomplished by a Likert scale ranging from "not satisfied" to "somewhat satisfied" to "moderately satisfied" to "quite a bit satisfied". with increasing answers indicating increased satisfaction with the Percutaneous nerve evaluation procedural experience.
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 0 | |
| Placebo | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 2 | |
| Placebo | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 4 | |
| Placebo | 7 |
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 14 | |
| Placebo | 9 |
The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 12.7 | ± 4.7 |
| Placebo | 13.4 | ± 5.8 |
Amplitude of perineal sensation during the PNE procedure. This was accomplished with a 100mm Visual analog scale score. This scale had 0mm indicating no sensation through 100mm indicating the most sensation one has ever felt. This was assessed during percutaneous nerve evaluation stimulation. The aim of the percutaneous nerve evaluation procedure is to achieve high sensation in the region of interest during stimulation - a proxy for appropriate lead placement. Thus, high values on this 100mm Visual analog scale indicate a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 48 | ± 27 |
| Placebo | 41 | ± 24 |
Rate of successful stimulation and lead placement with the PNE procedure
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 20 | |
| Placebo | 19 |
The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine Patch | 14 | |
| Placebo | 13 |
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to undergo a medically indicated percutaneous nerve evaluation (PNE). VAS pain score, The volume of injectable lidocaine used, Patient Satisfaction Score, rate of successful PNE (defined as successful placement of wire in the S3 spinal foramen), and the amplitude of perineal stimulation on a Likert scale will be collected immediately after the procedure. Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be recorded at that time. Rate of progression to Sacral nerve stimulator implantation will be collected. The investigators hypothesize that patients in the lidocaine patch group will experience significantly less pain at the time of PNE as measured by a lower change in VAS pain score when compared with the control group.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05783219.
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