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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical lidocaine patch | Experimental | 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure |
|
| Placebo | Placebo Comparator | Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch | Drug | 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Satisfaction | Satisfaction score collected after PNE procedure. This was accomplished by a Likert scale ranging from "not satisfied" to "somewhat satisfied" to "moderately satisfied" to "quite a bit satisfied". with increasing answers indicating increased satisfaction with the Percutaneous nerve evaluation procedural experience. | immediately after PNE procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190 | Louisville | Kentucky | 40205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29641846 | Background | 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. | |
| 19937315 |
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There is no plan to make individual participant data (IPD) available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Lidocaine Patch | 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure Lidocaine patch: 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure 20 participants received the 4% lidocaine patch |
| FG001 | Placebo | Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure Placebo: Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure 19 participants received the 4% lidocaine patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Lidocaine Patch | 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure Lidocaine patch: 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure 20 participants received the 4% lidocaine patch |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | collected before and immediately after the PNE procedure |
|
6 months post-procedure
For this study, the following standard adverse event (AE) definitions are used:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Lidocaine Patch | 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure Lidocaine patch: 4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodger Rothenberger | University of Louisville Medical Center | (502) 588-7660 | Rodger.rothenberger@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2023 | Dec 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2023 | Dec 11, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This is a single-center, double-blinded, placebo-controlled, randomized trial.
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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.
| Placebo | Other | Adhesive patch placed over the sacrum 30 minutes prior to 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. This was accomplished with a 100mm Visual analog scale score. This scale had 0mm indicating no sensation through 100mm indicating the most sensation one has ever felt. This was assessed during percutaneous nerve evaluation stimulation. The aim of the percutaneous nerve evaluation procedure is to achieve high sensation in the region of interest during stimulation - a proxy for appropriate lead placement. Thus, high values on this 100mm Visual analog scale indicate a better outcome. | 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 6 months after the PNE procedure |
| ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office |
| Louisville |
| Kentucky |
| 40215 |
| United States |
| 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. |
| 9481151 | 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. |
| 23098785 | 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. |
| 25630918 | 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. |
| 28709886 | 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. |
| 12616661 | 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. |
| 30211382 | 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. |
| 11354213 | 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. |
| 40013530 | Derived | 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. |
Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure Placebo: Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure 19 participants received the 4% lidocaine patch |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Satisfaction | Satisfaction score collected after PNE procedure. This was accomplished by a Likert scale ranging from "not satisfied" to "somewhat satisfied" to "moderately satisfied" to "quite a bit satisfied". with increasing answers indicating increased satisfaction with the Percutaneous nerve evaluation procedural experience. | Posted | Number | Participants | immediately after PNE procedure |
|
|
|
| Secondary | Volume of Injectable Lidocaine Used | The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure | Posted | Mean | Standard Deviation | mL | collected after the PNE procedure |
|
|
|
| Secondary | Amplitude of Perineal Sensation. | Amplitude of perineal sensation during the PNE procedure. This was accomplished with a 100mm Visual analog scale score. This scale had 0mm indicating no sensation through 100mm indicating the most sensation one has ever felt. This was assessed during percutaneous nerve evaluation stimulation. The aim of the percutaneous nerve evaluation procedure is to achieve high sensation in the region of interest during stimulation - a proxy for appropriate lead placement. Thus, high values on this 100mm Visual analog scale indicate a better outcome. | Posted | Mean | Standard Deviation | mm | collected immediately after the PNE procedure |
|
|
|
| Secondary | Rate of Successful PNE | Rate of successful stimulation and lead placement with the PNE procedure | Posted | Count of Participants | Participants | collected immediately after the PNE procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | to be assessed 6 months after the PNE procedure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure Placebo: Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure | 0 | 19 | 0 | 19 | 0 | 19 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Moderately Satisfied |
|
| Quite A Bit Satisfied |
|