Oral vs Intravesical Analgesia for Office Bladder Botox Injections (OPIL)

Women and Infants Hospital of Rhode Island

Status and phase: Unknown; Phase 4

Conditions: Detrusor Hyperreflexia; Detrusor Instability; Urinary Incontinence; Overactive Bladder Syndrome; Urge Incontinence

Treatments: Drug: Lidocaine 2% Injectable Solution; Drug: Phenazopyridine

Study type: Interventional

Funder types: Other

Identifiers

NCT03755089

1258364-2

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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.
3. 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Oral Phenazopyridine

Active Comparator group

Description:

Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.

Treatment:

Drug: Phenazopyridine

Intravesical Lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine 2% Injectable Solution