A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Procedure Success
研究概览
简要总结
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.
详细描述
This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adult (18 years of age or older)
- •Able to undergo routine cystoscopy
- •Willing to provide verbal assessment of her condition within 5 days after the procedure
排除标准
- •History of urethral strictures
- •Presence of a suprapubic catheter or tube due to urethral trauma
- •history of interstitial cystitis
- •currently being treated for a urinary tract infection (UTI)
- •gross hematuria present
- •Known allergy or sensitivity to any component of the medication or solution to be injected during the study
- •is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study
- •cannot empty her bladder on her own and is routinely catheterizing the urethra
- •unable to read, understand, and/or provide a ranking of pain level during the procedure,
- •unable or unwilling to provide consent
结局指标
主要结局
Procedure Success
时间窗: 1 Day of the procedure
Percentage of subjects with successful injection of medication
次要结局
- Patient Tolerance of Injection(1 Day of the procedure)
- Adverse Events during Procedure(Day 0 and Day 5)