Modern Urodynamics System Efficacy (MUSE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Insertion Success
研究概览
简要总结
The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms.
The main question[s] it aims to answer are:
• What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms?
Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient must be ≥ 18 years of age
- •Patient must have a diagnosis of LUTD
- •Patient must be scheduled for or recommended for cUDS
- •Patient is able to tolerate 18Fr catheterization
- •Patient or patient's legally authorized representative is able to provide informed consent
排除标准
- •Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period.
- •Patient has a symptomatic UTI based on CDC guidance (see below)
- •Subjects who, at the principal investigator's determination, would not be appropriate for this study.
结局指标
主要结局
Percentage of Participants With Insertion Success
时间窗: during the insertion procedure of a device
Percent of insertion attempts of the Glean sensor deemed successful
Percentage of Participants With a Device-related SAE
时间窗: up to 2 weeks
Device-related serious adverse events
Percentage of Participants With Removal Success
时间窗: during the removal procedure of a device
Percent of removal attempts of the Glean sensor deemed successful
次要结局
- Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable(asked at end of Glean Urodynamics procedure)