Clinical trial NCT06695585: Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections
Official title: Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Urinary Urgency
Urinary Frequency
Urge Incontinence
Neurogenic Bladder
Keywords: Bladder Botox
Intravesical lidocaine
office Botox
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blinded, randomized superiority trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Detailed description: The volume of 2% intravesical lidocaine solution and efficacy for pain relief at the time of office intradetrusor Botox A injection has not been well studied. Studies evaluating intravesical lidocaine show that it is not sufficiently absorbed by human bladders to achieve serum toxicity levels and only provides superficial local anesthetic effect. Experts agree that intravesical local anesthetic can be given in the office, with approximately 30 to 40 mL of 2% lidocaine instilled via catheter into the bladder for about 20 minutes before injection. However, there is little evidence regarding this strategy, and future research would help standardize recommendations.

The purpose of our study is to evaluate the efficacy and safety of higher volume pre-procedure intravesical lidocaine solution for pain at the time of intradetrusor office Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Eligibility criteria: Inclusion Criteria:

* Adult female, \>18 years, English-speaking (surveys utilized are not validated in all languages)
* Able to provide informed consent
* Indications: Refractory urge urinary incontinence, Refractory urinary urgency and frequency, Neurogenic bladder (without sensory deficit)

Exclusion Criteria:

* Untreated urinary tract infection at the time of procedure
* Contra-indication to Botox
* Contraindication to intravesical lidocaine
* Inability to provide informed consent
* Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: on day of enrollment and procedure
Secondary outcomes:
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: through study completion, an average of 1 year
measure: Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)
timeFrame: This will be assessed pre and post-intervention for all participants through study completion, an average of 1 year
measure: Patient Satisfaction Questionnaire Short-Form (PSQ-18)
timeFrame: through study completion, an average of 1 year
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: through study completion, an average of 1 year
measure: Bladder diary
timeFrame: through study completion, an average of 1 year
measure: Post-void residual volume
timeFrame: through study completion, an average of 1 year
measure: Adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Sean Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.