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Phase 2 N=39 Randomized Quadruple-blind Treatment

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Overactive Bladder · Urge Incontinence · Fecal Incontinence

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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