Overactive Bladder, Urge Incontinence, Fecal Incontinence
Conditions
Keywords
lidocaine
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.
Interventions
DRUGLidocaine patch
4% lidocaine patch placed over the sacrum 30 minutes prior to PNE procedure
OTHERPlacebo
Adhesive patch placed over the sacrum 30 minutes prior to PNE procedure
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention model description
This is a single-center, double-blinded, placebo-controlled, randomized trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female patients undergoing sacral neuromodulation to manage their OAB with sacral neuromodulation trial with percutaneous nerve evaluation (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 contraindications to SNM including pregnancy 3. Allergy to lidocaine or adhesives 4. Chronic pain as an indication for the PNE procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Placebo | Total | Topical Lidocaine Patch |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 12 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 27 Participants | 17 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 14 | 62 years STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 34 Participants | 16 Participants |
| Region of Enrollment United States | 19 participants | 39 participants | 20 participants |
| Sex: Female, Male Female | 19 Participants | 39 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
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.
Time frame: collected before and immediately after the PNE procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine Patch | Visual Analog Scale Pain Score | 45 mm | Standard Deviation 17 |
| Placebo | Visual Analog Scale Pain Score | 61 mm | Standard Deviation 21 |
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.
Time frame: collected immediately after the PNE procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine Patch | Amplitude of Perineal Sensation. | 48 mm | Standard Deviation 27 |
| Placebo | Amplitude of Perineal Sensation. | 41 mm | Standard Deviation 24 |
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.
Time frame: immediately after PNE procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical Lidocaine Patch | Overall Satisfaction | Not Satisfied | 0 Participants |
| Topical Lidocaine Patch | Overall Satisfaction | Somewhat Satisfied | 2 Participants |
| Topical Lidocaine Patch | Overall Satisfaction | Moderately Satisfied | 4 Participants |
| Topical Lidocaine Patch | Overall Satisfaction | Quite A Bit Satisfied | 14 Participants |
| Placebo | Overall Satisfaction | Quite A Bit Satisfied | 9 Participants |
| Placebo | Overall Satisfaction | Not Satisfied | 0 Participants |
| Placebo | Overall Satisfaction | Moderately Satisfied | 7 Participants |
| Placebo | Overall Satisfaction | Somewhat Satisfied | 3 Participants |
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
Time frame: to be assessed 6 months after the PNE procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Lidocaine Patch | Rate of Progression to Permanent SNS Implantation | 14 Participants |
| Placebo | Rate of Progression to Permanent SNS Implantation | 13 Participants |
Secondary
Rate of Successful PNE
Rate of successful stimulation and lead placement with the PNE procedure
Time frame: collected immediately after the PNE procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Lidocaine Patch | Rate of Successful PNE | 20 Participants |
| Placebo | Rate of Successful PNE | 19 Participants |
Secondary
Volume of Injectable Lidocaine Used
The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure
Time frame: collected after the PNE procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine Patch | Volume of Injectable Lidocaine Used | 12.7 mL | Standard Deviation 4.7 |
| Placebo | Volume of Injectable Lidocaine Used | 13.4 mL | Standard Deviation 5.8 |