Overactive Bladder Clinical Trial
Official title:
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
NCT number | NCT05783219 |
Other study ID # | 22.0973 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | April 1, 2024 |
Verified date | May 2024 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190 | Louisville | Kentucky |
United States | ULP Female Pelvic Medicine and Reconstructive Surgery - Urogynecology Associates office | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville |
United States,
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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. — View Citation
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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. — View Citation
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. — View Citation
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale pain score | Visual Analog Scale pain score change (denoting the difference between pre- and post-procedural pain score). This scale ranges from 0-10. Higher Visual Analog Scale pain scores indicate worsening pain. | collected before and immediately after the PNE procedure | |
Secondary | Overall satisfaction | Satisfaction score collected after PNE procedure | immediately after PNE procedure | |
Secondary | Volume of injectable lidocaine used | The volume in milliliters of injectable lidocaine used for analgesia with the PNE procedure | collected after the PNE procedure | |
Secondary | Amplitude of perineal sensation | Amplitude of perineal sensation during the PNE procedure - collected on a likert scale | collected immediately after the PNE procedure | |
Secondary | Rate of successful PNE | Rate of successful stimulation and lead placement with the PNE procedure | 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 | to be assessed 3 months after the PNE procedure |
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