Trial Outcomes & Findings for Lidocaine Patches Prior to Percutaneous Nerve Evaluation (NCT NCT05783219)

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

collected before and immediately after the PNE procedure

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	20	19
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 16 • n=5 Participants	57 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: collected before and immediately after the PNE procedure

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Visual Analog Scale Pain Score	45 mm Standard Deviation 17	61 mm Standard Deviation 21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Overall Satisfaction Not Satisfied	0 Participants	0 Participants
Overall Satisfaction Somewhat Satisfied	2 Participants	3 Participants
Overall Satisfaction Moderately Satisfied	4 Participants	7 Participants
Overall Satisfaction Quite A Bit Satisfied	14 Participants	9 Participants

SECONDARY outcome

Timeframe: collected after the PNE procedure

The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Volume of Injectable Lidocaine Used	12.7 mL Standard Deviation 4.7	13.4 mL Standard Deviation 5.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Amplitude of Perineal Sensation.	48 mm Standard Deviation 27	41 mm Standard Deviation 24

SECONDARY outcome

Timeframe: collected immediately after the PNE procedure

Rate of successful stimulation and lead placement with the PNE procedure

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Rate of Successful PNE	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Topical Lidocaine Patch n=20 Participants 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	Placebo n=19 Participants 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
Rate of Progression to Permanent SNS Implantation	14 Participants	13 Participants

Adverse Events

Topical Lidocaine Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rodger Rothenberger

University of Louisville Medical Center

Phone: (502) 588-7660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place