在患有膀胱过度活动症 (OAB) 症状的男性前列腺钬激光摘除术 (HoLEP) 时检查逼尿肌内肉毒杆菌毒素的影响
一项多中心随机对照试验，检查逼尿肌内肉毒杆菌毒素在膀胱过度活动症 (OAB) 症状男性前列腺钬激光摘除术 (HoLEP) 时的影响
The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
研究概览
详细说明
Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males 18 -89 undergoing HoLEP
- Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires.
Exclusion Criteria:
- Allergy or hypersensitivity to OnabotulinumtoxinA injections
- Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
- Anticipated need for perineal urethrostomy at the time of HoLEP
- Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
- Patients who lack decisional capacity
- Active urinary tract infection
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intra-detrusor OnabotulinumtoxinA Injection
Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed. |
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
其他名称：
|
|
无干预：No intra-detrusor OnabotulinumtoxinA Injection
Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
大体时间：12 months
|
Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in safety/ adverse effects
大体时间：90 days
|
Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications. |
90 days
|
|
Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)
大体时间：6 months
|
Identifying symptom resolution at different time points (1 month, 3 months, 6 months) |
6 months
|
|
Difference in efficacy endpoints (3-month clinic/telephone follow-up)
大体时间：3 months
|
Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any. |
3 months
|
合作者和调查者
调查人员
- 首席研究员：Amy Krambeck, MD、Northwestern University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STU00218130
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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