Oral vs Intravesical Analgesia for Office Bladder Botox Injections

Urinary Incontinence Clinical Trial

— OPIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03755089
• Other study ID #: 1258364-2
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2020
• Source: Women and Infants Hospital of Rhode Island
• Contact: Lauren E Stewart, MD
• Phone: 401-453-7560
• Email: lstewart[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Detrusor Hyperreflexia
• Detrusor Instability
• Overactive Bladder Syndrome
• Reflex, Abnormal
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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