Phase 2
N=39
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
Overactive Bladder · Urge Incontinence · Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05783219 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Visual Analog Scale Pain Score — 45; 61 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lidocaine patch (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Louisville
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale Pain Score |
45; 61 | — |
| SECONDARY Overall Satisfaction |
0; 0; 2; 3; 4; 7 | — |
| SECONDARY Volume of Injectable Lidocaine Used |
12.7; 13.4 | — |
| SECONDARY Amplitude of Perineal Sensation. |
48; 41 | — |
| SECONDARY Rate of Successful PNE |
20; 19 | — |
| SECONDARY Rate of Progression to Permanent SNS Implantation |
14; 13 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female patients undergoing sacral neuromodulation to manage their OAB with sacral neuromodulation trial with percutaneous nerve evaluation (PNE) without fluoroscopy.
- No contraindication to the use of lidocaine patch
- Age >18 years old
Exclusion Criteria
- Patients who are not candidates for SNM therapy
- Patients with contraindications to SNM including pregnancy
- Allergy to lidocaine or adhesives
- Chronic pain as an indication for the PNE procedure
Data sourced from ClinicalTrials.gov (NCT05783219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.