Lidocaine Patches Prior to Percutaneous Nerve Evaluation

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Fecal Incontinence; Urge Incontinence
• Intervention / Treatment: Drug: Lidocaine patch; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rodger W Rothenberger, MD; Phone Number: 6106203936; Email: rwroth03@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Recruiting
      • ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
      • Contact: Rodger Rothenberger, MD; Phone Number: 502-977-5907; Email: rwroth03@louisville.edu
    • Louisville, Kentucky, United States, 40215
      • Recruiting
      • ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office
      • Contact: Rodger Rothenberger, MD; Phone Number: 502-977-5907; Email: rwroth03@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical lidocaine patch; 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure	Drug: Lidocaine patch; 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure
Placebo Comparator: Placebo; Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure	Other: Placebo; Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale pain score	Visual Analog Scale pain score change (denoting the difference between pre- and post-procedural pain score). This scale ranges from 0-10. Higher Visual Analog Scale pain scores indicate worsening pain.	collected before and immediately after the PNE procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction	Satisfaction score collected after PNE procedure	immediately after PNE procedure
Volume of injectable lidocaine used	The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure	collected after the PNE procedure
Amplitude of perineal sensation	Amplitude of perineal sensation during the PNE procedure - collected on a likert scale	collected immediately after the PNE procedure
Rate of successful PNE	Rate of successful stimulation and lead placement with the PNE procedure	collected immediately after the PNE procedure
Rate of progression to permanent SNS implantation	The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator	to be assessed 3 months after the PNE procedure

Collaborators and Investigators

• Sponsor: University of Louisville

Publications and helpful links

General Publications

• Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
• Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.
• Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24.
• Goldman HB, Lloyd JC, Noblett KL, Carey MP, Castano Botero JC, Gajewski JB, Lehur PA, Hassouna MM, Matzel KE, Paquette IM, de Wachter S, Ehlert MJ, Chartier-Kastler E, Siegel SW. International Continence Society best practice statement for use of sacral neuromodulation. Neurourol Urodyn. 2018 Jun;37(5):1823-1848. doi: 10.1002/nau.23515. Epub 2018 Apr 11.
• Schlenk EA, Erlen JA, Dunbar-Jacob J, McDowell J, Engberg S, Sereika SM, Rohay JM, Bernier MJ. Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36. Qual Life Res. 1998 Jan;7(1):57-65. doi: 10.1023/a:1008836922089.
• Gupta P, Ehlert MJ, Sirls LT, Peters KM. Percutaneous tibial nerve stimulation and sacral neuromodulation: an update. Curr Urol Rep. 2015 Feb;16(2):4. doi: 10.1007/s11934-014-0479-1.
• Siegel S, Noblett K, Mangel J, Bennett J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Zylstra S, Kan F, Berg KC. Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. J Urol. 2018 Jan;199(1):229-236. doi: 10.1016/j.juro.2017.07.010. Epub 2017 Jul 11.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Rectal Diseases; Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Fecal Incontinence; Urinary Incontinence, Urge; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 22.0973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes