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Not yet recruiting NCT06695585

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

Phase IV Interventional Overactive Bladder Overactive Bladder Syndrome Urinary Urgency Urinary Frequency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine 2% without vessel constrictor.
Who it may be relevant to
Registry conditions: Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Frequency. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial

Overview

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.

Interventions

  • Drug 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

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: on day of enrollment and procedure]
Secondary outcome measures (7)
  • Patient Global Impression of Severity (PGI-S) [Time frame: through study completion, an average of 1 year]
  • Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q) [Time frame: This will be assessed pre and post-intervention for all participants through study completion, an average of 1 year]
  • Patient Satisfaction Questionnaire Short-Form (PSQ-18) [Time frame: through study completion, an average of 1 year]
  • Patient Global Impression of Improvement (PGI-I) [Time frame: through study completion, an average of 1 year]
  • Bladder diary [Time frame: through study completion, an average of 1 year]
  • Post-void residual volume [Time frame: through study completion, an average of 1 year]
  • Adverse events [Time frame: through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery — Louisville

Publications

  • 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. PMID 25754188

Identifiers

NCT: NCT06695585 · 24.0636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗