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.
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)
Untreated urinary tract infection at the time of procedure
Contra-indication to Botox
Contraindication to intravesical lidocaine
Inability to provide informed consent
Parallel
Lidocaine 2% without vessel constrictor
Drugdifferent volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared
Visual Analog Scale (VAS)
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
Patient Global Impression of Severity (PGI-S)
Likert scale describing current severity of urinary tract condition: 1. Normal, 2. Mild, 3. Moderate, 4. Severe; higher scores indicate worse symptoms
Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)
An 11-item questionnaire that assesses patient satisfaction with their overactive bladder (OAB) treatment. It includes three sub-scales (satisfaction, side effects, and endorsement) and two single-item assessments (convenience and preference). Scores range from 0-100, higher scores indicate higher satisfaction with treatment. Used to assess treatment satisfaction over time.
Patient Satisfaction Questionnaire Short-Form (PSQ-18)
An 8-item question assessing satisfaction with medical care experience, measured on a Likert scale with 1 "Strongly agree" and 5 "Strongly disagree", for questions 1-3, 5-6, and 8 lower scores indicate higher satisfaction. For questions 4 and 7 lower scores indicate dissatisfaction.
Patient Global Impression of Improvement (PGI-I)
7-point Likert scale with 1 indicating "Very much better" and 7 indicating "Very much worse", lower scores indicate more improvement
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This trial is not recruiting at the moment. You can still explore other options:
