Oral vs Intravesical Analgesia for Office Bladder Botox Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-03-01

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.

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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:

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

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Overactive Bladder Syndrome Urge Incontinence Urinary Incontinence Detrusor Hyperreflexia Detrusor Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Phenazopyridine

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

Group Type ACTIVE_COMPARATOR

Phenazopyridine

Intervention Type DRUG

200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure

Intravesical Lidocaine

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.

Group Type ACTIVE_COMPARATOR

Lidocaine 2% Injectable Solution

Intervention Type DRUG

30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure

Interventions

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Phenazopyridine

200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure

Intervention Type 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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No