Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Temperature increase
研究概览
简要总结
The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. Simultaneous measurements with the RigiScan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for erectile dysfunction diagnostics.
详细描述
Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunction diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer without (a history of) erectile dysfunction
- •Aged 18 - 29 years
排除标准
- •Test subjects who are unwilling to sign informed consent
- •Test subjects with erectile dysfunction
- •IIEF-5 score of below 17
- •(History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
- •(History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
- •Usage of sleeping pills or benzodiazepines.
研究组 & 干预措施
Nocturnal erection measurement
Overnight measurements of the temperature of the penile skin and outer thigh will be performed, while simultaneously the penile circumference and rigidity is determined by RigiScan measurements
干预措施: Feeling Hot sensor system (Device)
结局指标
主要结局
Temperature increase
时间窗: 8 hours
Increase in penile skin temperature during nocturnal erection
(De)tumescence duration
时间窗: 8 hours
Duration of increased penile skin temperature during erection
次要结局
- Difference between sexual and nocturnal erections(8 hours)
研究者
Hille Torenvlied
Coordinating Investigator
St. Antonius Hospital