CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Lidocaine patch +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05783219
NCT05783219Phase 2Completed

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

University of Louisville·interventional·Posted Mar 24, 2023·Updated Feb 3, 2025

In Brief

A Phase 2 clinical trial evaluating Lidocaine patch and Placebo for Overactive Bladder and 2 related conditions. Completed, enrolled 39 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedMar 24, 2023
Enrollment StartMay 1, 2023
Primary CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.3 years ago

Interventions

Lidocaine patchdrug

4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure

Placeboother

Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure