跳至主要内容
临床试验/NCT05219071
NCT05219071已完成不适用

Transdermal Rigidity Assessment Via Ischemia (and Temperature) of the Penis (TRIP) Versus the Rigiscan: A New Sensor-driven Device to Measure Rigidity of the Penis

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年6月20日最近更新:
适应症

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
Change in saturation

研究概览

简要总结

In men without erectile problems, night time erections occur during the REM-sleep. For this study the current diagnostic test, the Rigiscan is compared, with the data from the TRIP-Patch during the night. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis. Eventually, to have a validated device, a patch in the size of a postage stamp, that easily measures erectile function at home. Furthermore the temperature on the outside of the thigh will be measured.

详细描述

Background of the study: Erectile dysfunction (ED) is defined as the persistent or recurrent inability to attain and maintain an erection sufficient to perform sexual activity. ED has an effect on physical and psychosocial well-being. The current diagnostic test, the Rigiscan to measure night time erections, has a lot of disadvantages.

When an erection occurs and there is no inflow and outflow in the corpora cavernosa it is expected that the saturation will drop. As known with low flow priapism. From a study from Solnick, the mean skin temperature in younger male (19-33 years old) increases from 33,8°C to 36.2°C during arousal. A penile oximeter and temperature sensor was developed, to measure saturation and temperature of the penis during the night. The TRIP-Patch (Transdermal Rigidity assessment via Ischemia of the Penis) is expected to continuously measure saturation levels in the corpora cavernosa by real time monitoring with a photodiodes and LEDs and the sensor has a temperature logger.

Objective of the study: see above Study design: Observational study Study population: Healthy volunteers are asked to participate after informed consent. Age between 18 and 40 years. Both sensors and the Rigiscan will be placed at the same time, when 10 patients have night time erections with the Rigiscan, the study is complete.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers without (a history of) erectile dysfunction
  • Signed informed consent
  • Between 18-40 year

排除标准

  • Volunteers who are unwilling to sign written informed consent
  • Volunteers with sickle cell anemia because this could affect the accuracy of the measurements
  • Volunteers with erectile dysfunction

结局指标

主要结局

Change in saturation

时间窗: 1 night

Change in saturation of corpora cavernosa during an erection

temperature change

时间窗: 1 night

Change in penile skin temperature during an erection

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

Evelien Trip

Principal Investigator

St. Antonius Hospital

研究点 (1)

Loading locations...

相似试验