Oral Phenazopyridine Versus Intravesical Lidocaine for Office OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Analgesic Effect Measured with 100mm Visual Analog Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral Phenazopyridine
Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.
干预措施: Phenazopyridine (Drug)
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.
干预措施: Lidocaine 2% Injectable Solution (Drug)
结局指标
主要结局
Analgesic Effect Measured with 100mm Visual Analog Scale
时间窗: Immediately post-procedure
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.
次要结局
- Overall Patient Satisfaction(Immediately post-procedure)
- Office Efficiency/Total Appointment Duration(Immediately post-procedure)
- Ease of Procedure(Immediately post-procedure)