39 Participants Needed

Lidocaine Patch for Overactive Bladder

Recruiting at 1 trial location
RW
Overseen ByRodger W Rothenberger, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Louisville
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests if a lidocaine patch can reduce pain for patients undergoing a PNE procedure. The patch numbs the lower back to make the procedure less painful. Patients' pain levels and satisfaction will be measured. Lidocaine patches have been used to treat various types of pain, including nerve pain, pain after shingles, and pain after surgery, with mixed results.

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.

What data supports the effectiveness of the lidocaine patch treatment for overactive bladder?

Research shows that lidocaine, a local anesthetic, can help with overactive bladder symptoms when used directly in the bladder in both animal and human studies. Additionally, studies on similar conditions like bladder pain syndrome suggest lidocaine can affect bladder-related symptoms.12345

Is the lidocaine patch safe for humans?

The research does not provide specific safety data for the lidocaine patch used for overactive bladder, but lidocaine is commonly used as a local anesthetic in medical procedures, suggesting it is generally considered safe when used appropriately.36789

How does the lidocaine patch treatment for overactive bladder differ from other treatments?

The lidocaine patch for overactive bladder is unique because it uses a local anesthetic to block nerve signals in the bladder, potentially reducing symptoms without affecting bladder muscle contractions. This is different from standard treatments like anticholinergics, which reduce bladder muscle activity, or botulinum toxin injections, which require more invasive administration.125710

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Lidocaine patch
  • Placebo
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

References

Effects of 1% Lidocaine Instillation on Overactive Bladder Induced by Bladder Outlet Obstruction in Rats. [2021]
Diagnostic value of intravesical lidocaine for overactive bladder. [2015]
The placebo effect in overactive bladder syndrome. [2021]
What affects the placebo effect? [2020]
Prospective comparative study of the effects of lidocaine on urodynamic and sensory parameters in bladder pain syndrome. [2020]
Optimum Dose of Once-Daily Oxybutynin Patch in Japanese Patients with Overactive Bladder: A Randomized Double-Blind Trial Versus Placebo. [2017]
Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. [2022]
Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. [2013]
Overactive bladder: OTC oxybutynin transdermal patch for women. [2017]
[Capsaicin and lidocaine usage in functional disorders of urinary bladder]. [2017]