NCT03755089

Oral vs Intravesical Analgesia for Office Bladder Botox Injections

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Overactive Bladder Syndrome
• Urge Incontinence
• Urinary Incontinence
• Detrusor Hyperreflexia
• Detrusor Instability

Interventions

Type	Name	Description
DRUG	Phenazopyridine	200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
DRUG	Lidocaine 2% Injectable Solution	30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-11-27
• Last updated: 2020-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study