CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
研究概览
简要总结
With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.
详细描述
Overactive bladder (OAB) is defined by the International Continence Society as urinary frequency and urgency, with or without urge urinary incontinence. The burden of OAB on the American public is immense in both human and financial terms. Despite this burden, there is a lack of effective diagnostic and treatment modalities for OAB. Other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of OAB and measure the effects of treatment on bladder physiology. Newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. Intravesical botulinum toxin is a minimally invasive treatment for OAB refractory to medical therapy. Despite the widespread use of intravesical botulinum toxin injection for OAB refractory to medical therapy, to date the optimal placement of the drug has not been determined. Typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. However, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after Botox®. This lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of Botox® on bladder filling and emptying in a three-dimensional fashion. CineMRI-UDS will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Overactive bladder symptoms
排除标准
- •Age less than 21 years
- •Inability to give informed consent
- •Claustrophobic
研究组 & 干预措施
Arm 1
Botulinum toxin and cineMRI-UDS
干预措施: Botulinum toxin and cineMRI-UDS (Other)
结局指标
主要结局
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
时间窗: About 10 Months
CineMRI and urodynamics technology will be used to obtain time-resolved views of the human bladder during filling and voiding. The investigators aim to reveal a new understanding of diseased lower urinary tract physiology during pre and post treatment.
次要结局
未报告次要终点
研究者
Jennifer T. Anger
MD
Cedars-Sinai Medical Center
