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临床试验/NCT05157295
NCT05157295Unknown4 期

Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Augusta University0 个研究点目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
主要终点
Perceived pain of each participant before, during, and after the procedure on a scale of 0-10

研究概览

简要总结

Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • females, adults 18 years of age and older, diagnosed with OAB

排除标准

  • bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients

研究组 & 干预措施

Experimental Group

Experimental

100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome.

干预措施: OnabotulinumtoxinA (Drug)

Control Group

Active Comparator

100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome.

干预措施: OnabotulinumtoxinA (Drug)

结局指标

主要结局

Perceived pain of each participant before, during, and after the procedure on a scale of 0-10

时间窗: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention

The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).

次要结局

  • Change in extent of Overactive Bladder Symptoms before and after receiving the procedure(Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure)
  • The Prevalence of complications with botox after receiving the procedure(2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure)
  • The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure(2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure)

研究者

申办方类型
Other
责任方
Sponsor

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