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Lidocaine Patch for Overactive Bladder

Phase 2

Recruiting

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No contraindication to the use of lidocaine patch

Female patients undergoing sacral neuromodulation to manage their OAB with sacral neuromodulation trial with percutaneous nerve evaluation (PNE) without fluoroscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed 3 months after the pne procedure

Awards & highlights

Study Summary

This trial will compare a lidocaine patch to a placebo to see if it reduces pain during a medically indicated procedure. Patients will be followed up to assess satisfaction and adverse events.

Who is the study for?

This trial is for women over 18 with overactive bladder (OAB) who are scheduled for a nerve evaluation procedure without fluoroscopy and have no allergies to lidocaine or adhesives. It's not suitable for those not eligible for sacral neuromodulation therapy, pregnant women, or those getting the procedure for chronic pain.Check my eligibility

What is being tested?

The study tests if a 4% lidocaine patch reduces pain more effectively than a placebo when applied before a percutaneous nerve evaluation. Researchers will measure pain levels, satisfaction, amount of injectable lidocaine used, success of wire placement in the spine, and stimulation strength.See study design

What are the potential side effects?

Possible side effects include pain at the patch site or changes in sensation. Since it involves standard care procedures after applying either the lidocaine or placebo patch, other typical risks of these procedures may also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can use lidocaine patches without any health risks.

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I am a woman getting a specific bladder control device test without X-ray guidance.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed 3 months after the pne procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed 3 months after the pne procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed 3 months after the pne procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Analog Scale pain score

Secondary outcome measures

Amplitude of perineal sensation

Overall satisfaction

Rate of progression to permanent SNS implantation

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: topical lidocaine patchExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine patch

2021

Completed Phase 3

~350

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,950 Total Patients Enrolled

Media Library

topical lidocaine patch Clinical Trial Eligibility Overview. Trial Name: NCT05783219 — Phase 2

Bowel Incontinence Research Study Groups: topical lidocaine patch, Placebo

Bowel Incontinence Clinical Trial 2023: topical lidocaine patch Highlights & Side Effects. Trial Name: NCT05783219 — Phase 2

topical lidocaine patch 2023 Treatment Timeline for Medical Study. Trial Name: NCT05783219 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any risk in using a lidocaine patch topically?

"Our team at Power judged that the topical lidocaine patch was a 2 on a scale of 1 to 3 due to its Phase 2 trial certifying. Although there is some evidence validating safety, efficacy has yet to be clinically established."

Answered by AI

Are there still vacancies for individuals to join this clinical experiment?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical experiment is currently enrolling patients. It was originally published on May 1st 2023 and subsequently updated on May 11th of that same year. The trial requires 34 participants to be recruited from two locations."

Answered by AI

What is the current enrollment count for this clinical experiment?

"Affirmative. Perusing the information available on clinicaltrials.gov, we can deduce that this research project has been open since May 1st 2023 and is currently in search of 34 participants from 2 different establishments."

Answered by AI

What outcome is this clinical trial hoping to achieve?

"The primary outcome that will be tracked during this clinical trial, both prior to and following the PNE intervention, is VAS Pain Score. Secondary outcomes include Overall Satisfaction as measured by a satisfaction score after treatment, Rate of Successful Stimulation with PNE procedure, and Amplitude of Perineal Sensation recorded on a Likert Scale."

Answered by AI

Recent research and studies

JAAOS: Global Research and ReviewsJournal

Validation of Digital Visual Analog Scale Pain Scoring with a Traditional Paper-based Visual Analog Scale in Adults

Delgado, Domenica A., Bradley S. Lambert, Nickolas Boutris, Patrick C. McCulloch, Andrew B. Robbins, Michael R. Moreno, and Joshua D. Harris. 2018. “Validation of Digital Visual Analog Scale Pain Scoring with a Traditional Paper-based Visual Analog Scale in Adults”. JAAOS: Global Research and Reviews. Ovid Technologies (Wolters Kluwer Health). doi:10.5435/jaaosglobal-d-17-00088.

clinicaltrials.govStudy

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Stacy Lenger MD 2023. "Lidocaine Patches Prior to Percutaneous Nerve Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05783219.