Lidocaine Patch for Overactive Bladder

No longer recruiting at 1 trial location

Overseen By Rodger W Rothenberger, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Louisville

Disqualifiers: Pregnancy, Lidocaine allergy, Chronic pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a lidocaine patch can reduce pain during a procedure for women with overactive bladder. Participants will receive either a real lidocaine patch or a placebo patch before their procedure to determine if the lidocaine patch increases comfort. The goal is to assess whether the lidocaine patch makes the procedure less painful and more satisfying for patients. Women with overactive bladder scheduled for a specific nerve procedure (without X-rays) may qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that lidocaine patches are usually safe and effective for pain relief. Studies with similar patches have found no major side effects. For example, one study found that people using a lidocaine patch experienced less pain than those using a placebo patch. Although specific data on using lidocaine patches for overactive bladder is lacking, the FDA has approved lidocaine for other uses, indicating its well-known safety profile. However, like any treatment, some individuals might experience minor side effects such as skin irritation. Prospective participants should discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for overactive bladder?

Unlike the standard treatments for overactive bladder, which often involve oral medications or surgeries, the lidocaine patch offers a unique approach by delivering medication directly through the skin. This topical delivery method targets the sacrum area to potentially provide relief with fewer systemic side effects. Researchers are excited about this treatment because it could offer a non-invasive and more convenient option, allowing patients to manage their symptoms without the need for pills or invasive procedures.

What evidence suggests that the lidocaine patch could be an effective treatment for overactive bladder?

Research has shown that lidocaine patches can reduce pain when used before certain medical procedures. In this trial, participants will receive either a 4% lidocaine patch or a placebo patch placed over the sacrum 30 minutes before the PNE procedure. One study found that patients using a 4% lidocaine patch experienced less pain during a specific nerve test compared to those using a patch without an active ingredient. Additionally, lidocaine in other forms has increased bladder capacity, suggesting it might help manage overactive bladder symptoms by improving bladder function. While more research is needed, these findings offer hope that lidocaine patches could effectively reduce pain and improve bladder control. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can use lidocaine patches without any health risks.

I am older than 18 years.

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

Exclusion Criteria

I am not a candidate for sacral nerve modulation therapy.

I need the PNE procedure because of my chronic pain.

You cannot participate if you are pregnant or have reasons why SNM treatment is not safe for you.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4% lidocaine patch or placebo patch 30 minutes prior to the PNE procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the PNE procedure, including adverse events and satisfaction scores

1 week

1 visit (in-person)

Long-term Follow-up

Rate of progression to permanent SNS implantation is assessed

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine patch
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: topical lidocaine patch Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05783219

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

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 ...

2.

withpower.com

withpower.com/trial/phase-2-urinary-bladder-overactive-3-2023-4f118

Lidocaine Patch for Overactive Bladder · Info for Participants

Trial Overview The study tests if a 4% lidocaine patch reduces pain more effectively than a placebo when applied before a percutaneous nerve evaluation.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5565382/

Effectiveness of percutaneous tibial nerve stimulation in the ...

PTNS can indeed modulate the voiding and storage function of the bladder leading to an overall subjective improvement of symptoms in about 60% of the patients.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022534701648705

Urodynamic Effects of Intravesical Instillation of Lidocaine ...

A significant increase in bladder capacity was observed following administration of 1 and 4% lidocaine in patients tested longer than 1 year after spinal ...

5.

contemporaryobgyn.net

contemporaryobgyn.net/view/urodynamics-and-the-role-of-lidocaine

Urodynamics and the role of lidocaine

The use of 2% intraurethral lidocaine does not have any statistically or clinically significant effect on urodynamic filling or voiding ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5411198/

Lidocaine-prilocaine cream reduces catheter-related ...

Safety issues have always been a concern with topical anesthetics. No significant adverse effects were recorded in our study. Every effort ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002937822003702

Oral phenazopyridine vs intravesical lidocaine for bladder ...

Slightly more participants reported being “very satisfied” in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34).

8.

researchgate.net

researchgate.net/publication/11015163_Pharmacokinetics_and_safety_of_continuously_applied_lidocaine_patches_5

Pharmacokinetics and safety of continuously applied ...

Results: there was a significant reduction in pain scores and opioid consumption in the lidocaine patch group compared to the placebo group.