Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- University of Louisville
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Higher volume intravesical lidocaine
200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.
Intervention: Lidocaine 2% without vessel constrictor (Drug)
Lower volume intravesical lidocaine
30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.
Intervention: Lidocaine 2% without vessel constrictor (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: on day of enrollment and procedure
a. Determine the efficacy of pain relief via the Visual Analog Scale (VAS, scored 0-100 on 100 mm scale with 0 indicating no pain and 100 indicating the worst pain possible) in women randomized to 200 ml 2% lidocaine without epinephrine versus 30 ml 2% lidocaine without epinephrine prior to office intravesical onabotulinum toxin A (Botox) injections i. Perceived maximum VAS during the procedure and post-procedure ii. Superiority limit 20 mm on 100 mm VAS scale
Secondary Outcomes
- Patient Global Impression of Severity (PGI-S)(through study completion, an average of 1 year)
- Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)(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)(through study completion, an average of 1 year)
- Patient Global Impression of Improvement (PGI-I)(through study completion, an average of 1 year)
- Bladder diary(through study completion, an average of 1 year)
- Post-void residual volume(through study completion, an average of 1 year)
- Adverse events(through study completion, an average of 1 year)
Investigators
Sean Francis, MD
OBGYN Department Chair
University of Louisville