Neurogenic Bladder, Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Frequency, Urinary Urgency
Conditions
Keywords
Bladder Botox, Intravesical lidocaine, office Botox
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.
Interventions
different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, double-blinded, randomized superiority trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | through study completion, an average of 1 year | 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) | through study completion, an average of 1 year | 7-point Likert scale with 1 indicating Very much better and 7 indicating Very much worse, lower scores indicate more improvement |
| Patient Global Impression of Severity (PGI-S) | through study completion, an average of 1 year | Likert scale describing current severity of urinary tract condition: 1. Normal, 2. Mild, 3. Moderate, 4. Severe; higher scores indicate worse symptoms |
| Post-void residual volume | through study completion, an average of 1 year | Measure voided volume and obtain post-void residual volume either by bladder scan or straight catheterization in the office at 2-week follow up appointment (or additional time points if indicated) following bladder Botox injection |
| Adverse events | through study completion, an average of 1 year | All adverse events will be recorded and tracked, including urinary tract infection, urinary retention, persistent hematuria, or additional suspected procedural related complications |
| Bladder diary | through study completion, an average of 1 year | 3-day bladder diary with objective patient reported data reporting voids per day, frequency between voids (measured in minutes or hours), episodes of incontinence per day |
Countries
United States
Contacts
Primary ContactSean Francis, MD
Backup ContactLaurel Carbone, MD
Outcome results
None listed