What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include dietary changes, medications, pelvic floor exercises, and surgical interventions. For treatments similar to the 4% Lidocaine Patch, which involve local anesthetics, side effects may include localized skin reactions such as redness, itching, or irritation at the application site. Broader treatments like medications (e.g., antidiarrheals, laxatives) can cause side effects such as constipation, abdominal pain, and bloating. Pelvic floor exercises generally have minimal side effects but may cause temporary discomfort. Surgical options carry risks of infection, bleeding, and complications related to anesthesia.

What prior FDA approvals exist?

FDA-approved treatments for bowel incontinence primarily include medications and devices aimed at improving muscle control and reducing symptoms. While specific FDA approvals for local anesthetics like the 4% lidocaine patch for bowel incontinence are not detailed, similar treatments often involve the use of topical agents to manage pain and discomfort. For instance, lidocaine is commonly used in various forms to provide local anesthesia and pain relief in different medical procedures, including gastrointestinal endoscopic procedures and post-hemorrhoidectomy pain management.

What other types of research exist?

Promising alternatives to 4% lidocaine patches for bowel incontinence patients may include other local anesthetics such as bupivacaine or ropivacaine, which are used in various pain management protocols. Additionally, non-opioid pharmacotherapies like NSAIDs (e.g., ketorolac) or COX-2 inhibitors (e.g., parecoxib) could be considered for their analgesic properties. Consulting with a healthcare provider for personalized treatment options is recommended.

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Lidocaine Patch for Overactive Bladder

Phase 2

Waitlist Available

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

Must not have

Chronic pain as an indication for the PNE procedure

Patients who are not candidates for SNM therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed 3 months after the pne procedure

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need the PNE procedure because of my chronic pain.

Select...

I am not a candidate for sacral nerve modulation therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analog Scale pain score

Secondary study objectives

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

~390

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bowel incontinence, such as topical lidocaine and nifedipine ointments, work by providing local anesthesia and reducing sphincter pressure, respectively. Lidocaine, a local anesthetic, numbs the affected area, thereby reducing pain and discomfort. Nifedipine, a calcium channel blocker, helps to relax the anal sphincter, reducing pressure and facilitating healing of fissures. Phenylephrine, a vasoconstrictor, increases anal sphincter tone, which can help in managing incontinence. These mechanisms are important as they directly address the symptoms and underlying issues of bowel incontinence, improving patient comfort and quality of life.

Systematic Review of Surgical Treatments for Fecal Incontinence.Management of faecal incontinence and constipation in adults with central neurological diseases.[Prospective, double-blind study of topical phenylephrine treatment for nocturnal fecal incontinence in patients after ileoanal pouch construction].