Clinical trial NCT03755089: Oral vs Intravesical Analgesia for Office Bladder Botox Injections
Official title: Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Urge Incontinence
Urinary Incontinence
Detrusor Hyperreflexia
Detrusor Instability
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesic Effect Measured with 100mm Visual Analog Scale
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Overall Patient Satisfaction
timeFrame: Immediately post-procedure
measure: Ease of Procedure
timeFrame: Immediately post-procedure
measure: Office Efficiency/Total Appointment Duration
timeFrame: Immediately post-procedure
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Lauren E Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart LE, Siddique M, Jacobs KM, Raker CA, Sung VW. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):308.e1-308.e8. doi: 10.1016/j.ajog.2022.05.025. Epub 2022 May 14.