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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overactive Bladder Overactive Bladder Syndrome Urinary Urgency Urinary Frequency Urge Incontinence Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, double-blinded, randomized superiority trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Higher volume intravesical lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine 2% without vessel constrictor

Intervention Type DRUG

different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared

Lower volume intravesical lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine 2% without vessel constrictor

Intervention Type DRUG

different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared

Interventions

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Lidocaine 2% without vessel constrictor

different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared

Intervention Type DRUG

Other Intervention Names

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onabotulinum toxin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No