Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Phase 2

Completed

Conditions: Urge Incontinence
Fecal Incontinence
Overactive Bladder

Interventions: Other: Placebo
Drug: Lidocaine patch

Registration Number: NCT05783219

Lead Sponsor: University of Louisville

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure
topical lidocaine patch	Lidocaine patch	4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score	collected before and immediately after the PNE procedure	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.

Secondary Outcome Measures

Name	Time	Method
Overall Satisfaction	immediately after PNE procedure	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.
Volume of Injectable Lidocaine Used	collected after the PNE procedure	The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure
Amplitude of Perineal Sensation.	collected immediately after the PNE procedure	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.
Rate of Successful PNE	collected immediately after the PNE procedure	Rate of successful stimulation and lead placement with the PNE procedure
Rate of Progression to Permanent SNS Implantation	to be assessed 6 months after the PNE procedure	The rate of successful reduction in urinary or fecal incontinence symptoms meriting placement of permanent sacral nerve stimulator

Trial Locations

Locations (2): ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
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Louisville, Kentucky, United States
ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office
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Louisville, Kentucky, United States