NCT05183620

Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Feeling Hot sensor system	The Feeling Hot sensor system consists of two temperature probes placed on the penis and the outer thigh of the test subject to measure skin temperature during erection

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-06-09
• Completion: 2022-07-27
• First posted: 2022-01-10
• Last updated: 2022-08-03

Locations

1 site across 1 country: Netherlands