Lidocaine Patches Prior to Percutaneous Nerve Evaluation

NCT ID: NCT05783219

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-04-01

Brief 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.

Detailed Description

The study design will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 30 minutes prior to the procedure to placebo patch. Intervention and control patches will be in envelopes labeled with study number and located within the procedure area. A patch from the envelope corresponding to the patient will be placed by a medical assistant or co-investigator who is not associated with the PNE placement procedure 30 minutes prior to the procedure start. Number of voids and incontinence episodes per day prior to the PNE procedure will be recorded. A patch (intervention or control) will be removed by a medical assistant prior to provider entering the room in order to secure blinding. 1% lidocaine 10cc will be injected into the sacral procedure site for adequate pain relief. PNE procedure will then be performed. If inadequate analgesia is reported by the Patient during the procedure, additional injectable lidocaine will be administered in 5 cc increments, not to exceed 4.5 mg/kg of injectable lidocaine. The volume of injectable lidocaine used will be recorded. VAS pain scores prior to and immediately after procedure will be recorded. Patient Satisfaction Score, rate of successful PNE, rate of progression to SNS implantation, and amplitude of perineal stimulation of 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. The overall satisfaction score will be recorded at that time.

Conditions

Overactive Bladder; Urge Incontinence; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

topical lidocaine patch

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

Group Type: EXPERIMENTAL

Lidocaine patch

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Lidocaine patch

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

2. No contraindication to the use of lidocaine patch

3. Age >18 years old

Exclusion Criteria

1. Patients who are not candidates for SNM therapy

2. Patients with contraindications to SNM including pregnancy

3. Allergy to lidocaine or adhesives

4. Chronic pain as an indication for the PNE procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Stacy Lenger MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190

Louisville, Kentucky, United States

ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office

Louisville, Kentucky, United States

Countries

United States

References

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Rothenberger RW, Henry T, Carbone L, Gaskins JT, Gupta A, Francis S, Lenger SM. Supplemental Lidocaine Patches Prior to Percutaneous Nerve Evaluation, a Randomized Trial. Urogynecology (Phila). 2025 Apr 1;31(4):377-383. doi: 10.1097/SPV.0000000000001624. Epub 2025 Feb 25.

Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

22.0973

Identifier Type: -

Identifier Source: org_study_id