Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections

University of Louisville (UOFL)

Status and phase: Not yet enrolling; Phase 4

Conditions: Urinary Urgency; Urinary Frequency; Neurogenic Bladder; Overactive Bladder Syndrome; Urge Incontinence; Overactive Bladder

Treatments: Drug: Lidocaine 2% without vessel constrictor

Study type: Interventional

Funder types: Other

Identifiers

NCT06695585

24.0636

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Higher volume intravesical lidocaine

Active Comparator group

Description:

200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.

Treatment:

Drug: Lidocaine 2% without vessel constrictor

Lower volume intravesical lidocaine

Active Comparator group

Description:

30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.

Treatment:

Drug: Lidocaine 2% without vessel constrictor