A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
研究概览
简要总结
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.
详细描述
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 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intra-detrusor OnabotulinumtoxinA Injection
Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
时间窗: 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.
次要结局
- Difference in safety/ adverse effects(90 days)
- Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)(6 months)
- Difference in efficacy endpoints (3-month clinic/telephone follow-up)(3 months)
研究者
Amy Krambeck
Professor of Urology
Northwestern University