search
Back to results

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Primary Purpose

Overactive Bladder, Urge Incontinence, Fecal Incontinence

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine patch
Placebo
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190Recruiting
  • ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates officeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

topical lidocaine patch

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall satisfaction
Satisfaction score collected after PNE procedure
Volume of injectable lidocaine used
The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure
Amplitude of perineal sensation
Amplitude of perineal sensation during the PNE procedure - collected on a likert scale
Rate of successful PNE
Rate of successful stimulation and lead placement with 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

Full Information

First Posted
March 13, 2023
Last Updated
June 9, 2023
Sponsor
University of Louisville
search

1. Study Identification

Unique Protocol Identification Number
NCT05783219
Brief Title
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
Official Title
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Fecal Incontinence
Keywords
lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a single-center, double-blinded, placebo-controlled, randomized trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
topical lidocaine patch
Arm Type
Experimental
Arm Description
4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch
Intervention Description
4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure
Primary Outcome Measure Information:
Title
Visual Analog Scale pain score
Description
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.
Time Frame
collected before and immediately after the PNE procedure
Secondary Outcome Measure Information:
Title
Overall satisfaction
Description
Satisfaction score collected after PNE procedure
Time Frame
immediately after PNE procedure
Title
Volume of injectable lidocaine used
Description
The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure
Time Frame
collected after the PNE procedure
Title
Amplitude of perineal sensation
Description
Amplitude of perineal sensation during the PNE procedure - collected on a likert scale
Time Frame
collected immediately after the PNE procedure
Title
Rate of successful PNE
Description
Rate of successful stimulation and lead placement with the PNE procedure
Time Frame
collected immediately after the PNE procedure
Title
Rate of progression to permanent SNS implantation
Description
The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator
Time Frame
to be assessed 3 months after the PNE procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodger W Rothenberger, MD
Phone
6106203936
Email
rwroth03@louisville.edu
Facility Information:
Facility Name
ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodger Rothenberger, MD
Phone
502-977-5907
Email
rwroth03@louisville.edu
Facility Name
ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodger Rothenberger, MD
Phone
502-977-5907
Email
rwroth03@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers
Citations:
PubMed Identifier
29641846
Citation
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.
Results Reference
background
PubMed Identifier
19937315
Citation
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.
Results Reference
background
PubMed Identifier
9481151
Citation
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.
Results Reference
background
PubMed Identifier
23098785
Citation
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.
Results Reference
background
PubMed Identifier
25630918
Citation
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.
Results Reference
background
PubMed Identifier
28709886
Citation
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.
Results Reference
background
PubMed Identifier
12616661
Citation
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.
Results Reference
background
PubMed Identifier
30211382
Citation
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.
Results Reference
background
PubMed Identifier
11354213
Citation
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.
Results Reference
background

Learn more about this trial

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

We'll reach out to this number within 24 hrs