Oral vs Intravesical Analgesia for Office Bladder Botox Injections

Study Overview
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Brief Summary
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OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.

Detailed Description
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The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine. Secondary aims include assessment of: Overall Patient Satisfaction: To compare overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Office Efficiency/Total Appointment Duration: To compare total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.

Official Title
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Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial

Conditions
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Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Detrusor Instability

Intervention / Treatment
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* Drug: Phenazopyridine
* Drug: Lidocaine 2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pregnant, adult females 18 years of age or older Diagnosis of idiopathic overactive bladder Planning office-based bladder injection of onabotulinumtoxinA Willing and able to complete all study related items and interviews Grossly neurologically normal on exam Exclusion Criteria: Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete spinal cord injury) believed to affect urinary function Planned injection of >100 units of onabotulinumtoxinA OnabotulinumtoxinA given for another indication within the previous 3 months (if cumulative dose would total >400 units) Any intradetrusor onabotulinumtoxinA injections in the previous 12 months Serum creatinine level greater than twice the upper limit of normal within the year prior to enrollment Allergy to lidocaine Allergy to onabotulinumtoxinA Allergy to phenazopyridine Untreated urinary tract infection (UTI) Currently pregnant or lactating. Known urinary retention (post-void residual >200mL) and inability to perform intermittent self-catheterization Uninvestigated hematuria (gross or microscopic) Current or prior bladder malignancy Previous bladder augmentation or surgically altered detrusor muscle Prior pelvic radiation Primary language other than English or Spanish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Phenazopyridine<br>Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure. | Drug: Phenazopyridine<br>* 200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure<br>|
| Active Comparator: Intravesical Lidocaine<br>Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure. | Drug: Lidocaine 2% Injectable Solution<br>* 30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Effect Measured with 100mm Visual Analog Scale | The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line. | Immediately post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Patient Satisfaction | Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied. | Immediately post-procedure | 
| Ease of Procedure | Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty. | Immediately post-procedure | 
| Office Efficiency/Total Appointment Duration | Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out). | Immediately post-procedure |