跳至主要内容
临床试验/NCT02315950
NCT02315950招募中不适用

CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer T. Anger

MD

Cedars-Sinai Medical Center

研究点 (1)

Loading locations...

相似试验