Lidocaine Patches Prior to Percutaneous Nerve Evaluation

NCT05783219 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 22.0973
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Overactive Bladder; Urge Incontinence; Fecal Incontinence

Keywords

lidocaine

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale Pain Score

  Visual Analog Scale pain score (indicating the difference between pre and post-procedural pain scores). The scores in question were 100 mm visual analog scale pain scores. This scale ranges from 0-100mm. Higher 100mm Visual Analog Scale pain scores indicate worsening pain.

  collected before and immediately after the PNE procedure

Secondary Outcomes (5)

• Overall Satisfaction

  immediately after PNE procedure

• Volume of Injectable Lidocaine Used

  collected after the PNE procedure

• Amplitude of Perineal Sensation.

  collected immediately after the PNE procedure

• Rate of Successful PNE

  collected immediately after the PNE procedure

• Rate of Progression to Permanent SNS Implantation

  to be assessed 6 months after the PNE procedure

Study Arms (2)

topical lidocaine patch

EXPERIMENTAL

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

Drug: Lidocaine patch

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lidocaine patch DRUG

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

topical lidocaine patch

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients undergoing sacral neuromodulation to manage their OAB with sacral neuromodulation trial with percutaneous nerve evaluation (PNE) without fluoroscopy.
• No contraindication to the use of lidocaine patch
• Age \>18 years old

You may not qualify if:

• Patients who are not candidates for SNM therapy
• Patients with contraindications to SNM including pregnancy
• Allergy to lidocaine or adhesives
• Chronic pain as an indication for the PNE procedure

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (2)

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

Louisville, Kentucky, 40205, United States

Location

ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office

Louisville, Kentucky, 40215, United States

Location

Related Publications (10)

• 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.

  PMID: 29641846 BACKGROUND

• 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.

  PMID: 19937315 BACKGROUND

• 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.

  PMID: 9481151 BACKGROUND

• 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.

  PMID: 23098785 BACKGROUND

• 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.

  PMID: 25630918 BACKGROUND

• 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.

  PMID: 28709886 BACKGROUND

• 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.

  PMID: 12616661 BACKGROUND

• 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.

  PMID: 30211382 BACKGROUND

• 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.

  PMID: 11354213 BACKGROUND

• 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.

  PMID: 40013530 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Rodger Rothenberger
• Organization: University of Louisville Medical Center

Rodger.rothenberger@louisville.edu

(502) 588-7660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization sequence will be generated by statistician collaborator 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, double-blinded, placebo-controlled, randomized trial.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: May 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)