A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.
详细描述
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •At least 18 years of age
- •Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
- •Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
- •Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
- •Able to give informed consent
排除标准
- •Male gender
- •Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
- •Acute urinary tract infection
- •Treatment with Botox® toxin for other conditions
- •Allergy to Botox® toxin
- •Hematuria that has not been worked up
- •Known bladder malignancy
- •Previous history of bladder augmentation
- •Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
- •Currently taking aminoglycoside antibiotics
- •Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
- •History of chronic pain or pain syndromes
研究组 & 干预措施
10 Botox Injections
100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
干预措施: OnabotulinumtoxinA 100 Units (Drug)
20 Botox Injections
100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
干预措施: OnabotulinumtoxinA 100 Units (Drug)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Post Procedure Day 1
The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.
次要结局
- Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life(Baseline)
- Difference in Mean Urge Incontinence Episodes(Week 12 after procedure)
- Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms(12 weeks post procedure)
- Post-Void Residual (PVR)(12 weeks post procedure)
- Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life(12 weeks post procedure)