Status:
UNKNOWN
Oral vs Intravesical Analgesia for Office Bladder Botox Injections
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Overactive Bladder Syndrome
Urge Incontinence
Eligibility:
FEMALE
18-99 years
Phase:
PHASE4
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...
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 per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03755089
Start Date
November 1 2018
End Date
March 1 2021
Last Update
May 29 2020
Active Locations (1)
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1
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903