A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Post-void residual urinary volume (PVR)
研究概览
简要总结
To determine the safety and efficacy of the ThermaRx heating device for the application of controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).
详细描述
This study will assess the safety and efficacy of ThermaRx heat treatment in subjects who have urinary hesitancy.
The rationale for this approach is based on anecdotal evidence and case reports suggesting that urinary hesitancy can be effectively reduced by external skin heating (hot tub "Jacuzzi" effect, perineal hot water spray). However, to date, there have been no formal studies of this non-invasive form of treatment, and the mechanism of action is still unclear.
This is a two-day study in which each subject will receive an oral fluid load and then one (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will be performed both before and after voiding. On Day 1, voiding will be performed in a standing position; on Day 2, voiding will be done in a sitting position.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects 25-80 years of age at the screening visit.
- •Subject must have mild-to-moderate urinary hesitancy symptoms (shown as an American Urological Association Symptom Index (AUA-SI) score of 7-19).
- •Symptoms include (not limited to):
- •Leaking or dribbling of urine
- •More frequent urination, especially at night
- •Urgency to urinate
- •Urine retention (inability to urinate)
- •Hesitant, interrupter or weak stream of urine
- •Inability or difficulty to urinate in public
排除标准
- •History of prostate cancer or prostate surgery
- •Currently (or within the past 30 days) on active treatment for prostate problems
结局指标
主要结局
Post-void residual urinary volume (PVR)
时间窗: Both Study Day 1 & 2 before/after oral fluid load
次要结局
- Voided volume percentage (%) based on pre-void and post-void ultrasound volumes(Both Study Day 1 & 2 before/after oral fluid load)