Oral vs Intravesical Analgesia for Office Bladder Botox Injections (OPIL)
Primary Purpose
Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phenazopyridine
Lidocaine 2% Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
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
Sites / Locations
- Women & Infants Hospital of Rhode IslandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Phenazopyridine
Intravesical Lidocaine
Arm Description
Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT03755089
First Posted
November 26, 2018
Last Updated
May 27, 2020
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT03755089
Brief Title
Oral vs Intravesical Analgesia for Office Bladder Botox Injections
Acronym
OPIL
Official Title
Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Detrusor Hyperreflexia, Detrusor Instability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Phenazopyridine
Arm Type
Active Comparator
Arm Description
Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.
Arm Title
Intravesical Lidocaine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Phenazopyridine
Intervention Description
200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Intervention Description
30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure
Primary Outcome Measure Information:
Title
Analgesic Effect Measured with 100mm Visual Analog Scale
Description
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.
Time Frame
Immediately post-procedure
Secondary Outcome Measure Information:
Title
Overall Patient Satisfaction
Description
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.
Time Frame
Immediately post-procedure
Title
Ease of Procedure
Description
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.
Time Frame
Immediately post-procedure
Title
Office Efficiency/Total Appointment Duration
Description
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).
Time Frame
Immediately post-procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren E Stewart, MD
Phone
401-453-7560
Ext
48762
Email
lstewart@wihri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren E Stewart, MD
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren E Stewart, MD
Phone
401-453-7560
Ext
48762
Email
lstewart@wihri.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35580634
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.
Results Reference
derived
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Oral vs Intravesical Analgesia for Office Bladder Botox Injections
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