Lidocaine Patches Prior to Percutaneous Nerve Evaluation
Phase: PHASE2
Conditions: Overactive Bladder, Urge Incontinence, Fecal Incontinence
Sponsor: University of Louisville

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RESEARCH PROTOCOL 
STUDY TITLE: Lidocaine patches prior to percutaneous nerve evaluation 
 
IRB Protocol Number: 22.0973 
Trial Registration: completed  
 
Protocol version: 2 
Protocol Date: 02-21-2023 
Funding: None  
 
Principal Investigator:  
Dr. Stacy Lenger, MD  
Department of Obstetrics, Gynecology & Women’s Health 
Division of Female Pelvic Medicine and Reconstructive Surgery 
550 South Jackson Street 
Louisville, KY  40202    
 
Study Sites:  
• University of Louisville Hospital  

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• UofL Physicians – Urogynecology; Springs Medical Center Office 
• UofL Physicians – Urogynecology Associates; 4431 Churchman Avenue, Louisville, KY 
 
 
 
 

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Background/Problem Statement 
 
Sacral neuromodulation (SNM) is an accepted therapy for refractory urinary urgency and frequency, 
urgency urinary incontinence, non-obstructive urinary retention, and fecal incontinence1. A common 
indication for SNM is overactive bladder (OAB). OAB is defined as a syndrome of urinary urgency, 
usually accompanied by urinary frequency and nocturia, with or without urgency urinary 
incontinence, in the absence of infection or other pathology.2 OAB affects approximately 34 
million adults in the United States, substantially affecting their quality of life.3 The initial 
treatment for OAB consists of diet and behavioral modifications, pelvic floor physical therapy, 
bladder training, and a trial of anticholinergic or beta-agonist medications. However, long-term 
adherence to these interventions is poor due to side effects and poor effectiveness.4  
Sacral neuromodulation (SNM) is a third-line treatment option for OAB that can have a 
particular impact on this population and success rates as high as 82% can be expected at 5 
years.56 SNM is typically administered with a test stimulation followed by permanent 
battery/pulse generator placement if successful. Successful test stimulation is defined as a 
reduction of one or more micturition symptoms of ≥50% compared to baseline.  Test 
stimulation can be performed as a staged procedure in the operating room or as a percutaneous 
sacral nerve evaluation (PNE) performed in the office. Though a patient is anesthetized in the 
operating room, discomfort with placement is a larger concern with office based PNE procedures 
– making increased comfort with this procedure essential.  

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Lidocaine is frequently used for analgesia with PNE placement. This is often performed with 
injectable lidocaine, however, other forms can be considered to improve patient comfort and 
clinical success – namely through topical lidocaine patches. Up to 5% (35 mg) of lidocaine 
patches are absorbed topically, producing analgesia within 30 minutes with a half-life of 6 to 8 
hours7. Transdermally absorbed lidocaine appears to have a very low rate of systemic 
absorption resulting in local analgesia and not anesthesia, a characteristic not shared with 
lidocaine infiltration. The exact mechanism of this differential effect is unknown, however, it is 
hypothesized that the lidocaine patch produces analgesia without blocking all the sensory and 
motor inputs in large, myelinated A-β sensory fibers 7.  The value of this relatively rapid onset 
medication with analgesic effects and without the associated discomfort of infiltration can be 
increased comfort for patients. The ability to potentially detect adverse sensation more 
sensitively in the office may also make this method of analgesia more effective.  
 
Objectives 
Primary outcome will be: 
• VAS pain scores measured on a 10 point scale before and after PNE procedure 
Secondary outcomes will be: 
• Patient Overall Satisfaction after PNE placement 
• Volume of injectable lidocaine used 
• Rate of successful PNE  
• Progression to permanent SNS implantation.  
• Amplitude of perineal stimulation 

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Our null hypothesis is that there will be no significant difference in change in VAS score 
between patients in the lidocaine patch group and the patients in the control group. 
 
We hypothesize that patients in the lidocaine patch group will experience significantly less 
pain at the time of PNE as measured by change in VAS pain score when compared with the 
control group.  
 
Study Design/Methodology 
Patients who have been scheduled for a PNE procedure will be will be consented for the study on 
the day of the procedure and screened for participation prior to the procedure by phone. 
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 
collaboratorr. All data will be recorded in the RedCap software and be maintained in that 
password-protected format until analysis. Data analysis will be performed by researchers 
associated with the IRB for this study. De-identified data will also be sent to statistician 
collaborator for analysis. The trial is powered to detect a change in VAS pain score of 1.5 points 
or more on a 10 point scale, a value that is taken to be the minimum clinically meaningful 
change for the VAS instrument.8,9  Data on identification key will be deleted at the conclusion of 
this study. Patient enrollment will conclude when 34 subjects, 17 of each group, have been 
enrolled in the study.  Sample size was determined using G*Power so that we have 80% power 
to detect a difference between groups of the minimum clinically meaningful effect size of 1.5 

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points or greater using the two-sample test at α=0.05 and an assumed standard deviation for VAS 
score of 1.5 points.    
 
Inclusion criteria:  
1. Female patients undergoing sacral neuromodulation for the management of their OAB 
with SMN trial with 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 contraindication to SNM including pregnancy 
3.  Allergy to lidocaine or adhesives  
4. Chronic pain as an indication for the PNE procedure 
 
Study design 
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 

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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  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, 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. Overall satisfaction score will be 
recorded at that time.  
 
In summary, overall questionnaires and data being collected include: 
 
 
 
 
 
 
 

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Figure 1: Patient flow and outcomes:  
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent of patients scheduled to undergo 
PNE who meet inclusion/exclusion criteria 
EPIC review and subsequent Phone screen for 
participation followed by in clinic consent for 
Drug dispensation  
Lidocaine patch for 30 minutes 
prior to procedure  
Adhesive patch for 30 minutes 
prior to procedure 
PNE procedure performance. Measurement of VAS 
pain scale, Amplitude of perineal sensation, Volume 
of injectable lidocaine used, and Patient satisfaction 
scores are collected 
Rate of successful progression to stage II  

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Study has been registered on Clinicaltrials.gov 
 
 
Participant Recruitment Methods 
Subjects will be recruited from the ULP Female Pelvic Medicine and Reconstructive Surgery 
(FPMRS) practice at the University of Louisville Health Care Outpatient Center (HCOC), 
Urogynecology Associates office at 4431 Churchman Avenue and the Springs Medical Center. 
All Patients receiving care at University of Louisville Urogynecology who meet screening criteria 
will be called prior to their PNE procedure to assess for willingness to participate in this study. 
Women meeting study criteria will be approached by a member of the research team for 
consent prior to their PNE procedure. Women interested in the study will have the study 
explained to them, the consent reviewed, and questions addressed in a confidential manner in 
a private room. At the time of consent, participants will be informed that their participation in 
this research is voluntary and that they may discontinue participation without penalty at any 
time. Participants will not be reimbursed for their participation in this research study.  
 
 
Informed Consent Process 
Patients will be called prior to their procedure to assess if they are interested in participation in 
this study. If they are interested, they will present with sufficient time prior to their procedure 

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to review and sign their consent form and have their patch (lidocaine vs placebo) placed (in 
place for 30 minutes). Consent form is otherwise attached. 
 
Research Procedures 
Please see study design/methodology section for further details. In addition all members of the 
research team will be educated on the study protocol at a division meeting or meeting set up 
for training purposes.  All members of the research team will be able to ask questions at this 
education session and after the education session to ensure they are comfortable with all 
aspects of the study protocol. Members of the research staff that will be using REDCap 
(Research Electronic Data Capture) will be trained on how to use this database.  
 
 
Minimizing Risks 
Potential risk of breach of confidentiality will be mitigated by the redcap software and use of 
password protected University of Louisville computers for data entry and analysis. No one other 
than study investigators will be able to access data and it will be deleted at the conclusion of 
the study. Patient will be assigned a study number during the consent process and it will be 
associated with a patient identifier in REDCAP. No other location will have this information.  
 
As this study is minimal risk there will not be oversight of the data. As this drug is available over 
the counter and is not investigational, it will be placed in envelopes at the start of the study and 
dispensed by investigators and clinic staff.  

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All expected adverse events are of mild severity. 
For this study, the following standard adverse event (AE) definitions are used: 
• Adverse event: Any unfavorable and unintended sign, symptom, or disease temporally 
associated with the use of a medical treatment or procedure, regardless of whether it is 
considered related to the medical treatment or procedure. 
• Serious Adverse Event (SAE):  Any AE related to the study drug that results in any of the 
following circumstances:  death, life-threatening, event requiring inpatient hospitalization 
or prolongation of existing hospitalization, persistent or significant disability/incapacity 
 
AEs are graded according to the following scale: 
• Mild: An experience that is transient and requires no special treatment or intervention.  The 
experience does not generally interfere with usual daily activities.   
• Moderate: An experience that is alleviated with simple therapeutic treatments. The 
experience impacts usual daily activities.   
• Severe: An experience that require therapeutic intervention. The experience interrupts 
usual daily activities. If hospitalization (or prolongation of hospitalization) is required for 
treatment of something related to the study drug, it becomes a SAE.  
 
The study uses the follow AE attribution scale: 

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• Not related: The AE is clearly not related to the study procedure (i.e., another cause of the 
event is most plausible and/or a clinically plausible temporal sequence is inconsistent with 
the onset of the event). 
• Possibly related: An event that follows a reasonable temporal sequence from the initiation 
of study procedures, but that could readily have been produced by a number of other 
factors. 
• Related: The AE is clearly related to the study procedures.  
 
Expectedness of Adverse Events:  
• Uncommon: discomfort over the area the lidocaine patch was placed and discomfort with 
the PNE procedure itself  
• Rare: Allergy to adhesive bandage or lidocaine, lidocaine toxicity 
 
Plan for Analysis of Results 
Summary statistics for demographics, procedures variables, and outcome measures will be 
summarized for each treatment group (lidocaine patch and control patch) using means, 
standard deviations, counts and proportions, as appropriate.  Differences in these variables will 
be assessed using the two-sample t-test for continuous variables and the Fisher exact test for 
categorical variables.  A two-sample t-test will be used to assess differences in the primary 
outcome of change in VAS score after procedure between groups.  Differences in secondary 
outcomes will be considered using the two-sample t-test for continuous variables and the 

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Fisher exact test for categorical variables.  Transformations and/or non-parametric methods 
will be used if continuous data are found to substantially violate the assumption of approximate 
normality.  Multivariate linear/logistic regression models may be used to assess the impact of 
other variables onto primary or secondary outcomes.  Throughout, a significance level of 
α=0.05 will be used, and all tests will be two-sided.  Data analysis will be performed by a 
biostatistician collaborator using the R statistical software. 
 
Research Materials, Records, and Privacy 
 
Data that is to be collected with this study and entered into an encrypted database: 
 
Demographic data 
• Name 
• Date of birth 
• Age  
• Weight 
• BMI 
• Race/ethnicity 
• Smoking status  
• Indication for PNE 
• Contact information  
• Randomization assignment 

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• Study ID number 
• Number of voids and incontinence episodes per day prior to the PNE procedure and 1 
week after the PNE procedure  
Procedural variables:  
• Total amount of lidocaine used 
• Side of PNE lead stimulated 
• Amplitude of stimulation at completion of procedure 
 
• VAS pain score prior to and after the PNE procedure. 
• Satisfaction scale immediately post procedure and 1 week after the procedure. 
1-week follow up variables:  
• Adverse events of PNEs such as uncomfortable change in perineal sensation present at 
the 1 week post-procedure visit  
• Patient satisfaction score immediately after the PNE procedure and at the 1 week post-
procedure visit 
• Number of days with successful stimulation 
• Amplitude of stimulation at time of removal 
• Bladder/ fecal diary with symptoms during the PNE trial period 
 
3-month follow up 
• Number of patients with a “successful” PNE who underwent an implantation  
• Number of patients with a “successful” PNE who planned implantation but had not yet 
scheduled 

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• Number of patients with a “unsuccessful” PNE who underwent staged procedure 
• Number of patients with a “unsuccessful” PNE and what other treatment options they 
pursued in the next 3 months 
Successful PNE is defined as PNE procedure which resulted in successful wire placement. 
Unsuccessful PNE is defined as PNE procedure which did not result in successful wire 
placement. 
Implantation defined as stage 2 procedure after interval PNE results showed >/=50% symptom 
reduction. 
Staged procedure is a stage 1 procedure in the operating room as opposed to being performed 
as an outpatient PNE 
 
This information will be sourced from the subjects themselves and questionnaire templates for 
satisfaction score and VAS pain score will be attached to this document as appendices. This 
information is necessary to display if the intervention results in an increased comfort with the 
PNE procedure or increased satisfaction with the procedure. Number of voids and incontinence 
episodes before and after the PNE procedure is recorded to examine if a change in procedural 
effectiveness occurs with this intervention.  
 
All identifying information and data collected during the course of this study will be kept secure 
and strictly confidential. For confidentiality, only research team members will have access to 
the study information and the information entered into the database. Subjects will be assigned 

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a unique study ID that will be used on all case report forms and database reporting. The 
database that will be used is REDCap which is HIPPA (Health Insurance Portability and 
Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will 
be maintained in a locked cabinet in a locked office by a member of the research team.  
The research personnel involved in this study are CITI and HIPAA trained. If new research 
personnel are added to the study, an amendment will be submitted to and approved by the IRB 
before being allowed to participate in the study 
 
 
 
References 
 
1.  
Goldman HB, Hassouna MM, Lloyd JC, et al. International Continence Society best 
practice statement for use of sacral neuromodulation. 2018;(January):1-26. 
doi:10.1002/nau.23515 
2.  
Haylen BT, Ridder D de, Freeman RM, et al. An International Urogynecological 
Association (IUGA)/International Continence Society (ICS) joint report on the terminology 
for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29:4-20. doi:10.1002/nau 
3.  
Schlenk EA, Erlen JA, Dunbar-Jacob J, et al. Health-related quality of life in chronic 
disorders: A comparison across studies using the MOS SF-36. Qual Life Res. 1997;7(1):57-
65. doi:10.1023/A:1008836922089 
4.  
Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder 
(non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012;188(6 SUPPL.):2455-2463. 
doi:10.1016/j.juro.2012.09.079 
5.  
Gupta P, Ehlert MJ, Sirls LT, Peters KM. Percutaneous Tibial Nerve Stimulation and Sacral 
Neuromodulation: an Update. Curr Urol Rep. 2015;16(2):4-9. doi:10.1007/s11934-014-
0479-1 
6.  
Siegel S, Noblett K, Mangel J, et al. Five-Year Followup Results of a Prospective, 
Multicenter Study of Patients with Overactive Bladder Treated with Sacral 
Neuromodulation. J Urol. 2018;199(1):229-236. doi:10.1016/j.juro.2017.07.010 
7.  
Gammaitoni A, Alvarez N, Galer B. Safety and tolerability of the lidocaine patch 5%, a 
targeted peripheral analgesic: A review of the literature. J Clin Pharmacol. 
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8.  
Delgado DA, Lambert BS, Boutris N, et al. Validation of Digital Visual Analog Scale Pain 
Scoring With a Traditional Paper-based Visual Analog Scale in Adults. JAAOS Glob Res 

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Rev. 2018;2(3):e088. doi:10.5435/jaaosglobal-d-17-00088 
9.  
Kelly AM. The minimum clinically significant difference in visual analogue scale pain score 
does not differ with severity of pain. Emerg Med J. 2001;18(3):205-207. 
doi:10.1136/emj.18.3.205