Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis

St. Antonius Hospital

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Feeling Hot sensor system

Study type: Interventional

Funder types: Other

Identifiers

NCT05183581

79920

Details and patient eligibility

About

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 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. Healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize erectile dysfunction diagnostics.

Full 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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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 dysfunctions 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, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• Aged 18 - 29 years
• Capable of getting visually arousable erections

Exclusion criteria

• Test subject unwilling to sign informed consent
• Test subject with erectile dysfunction
• IIEF-5 score below 17
• Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Visually aroused erection (naked, clothing, blankets)

Other group

Description:

Randomisation of the order of visually aroused erection will be conducted: 1. Naked - Naked \& Blanket - Clothing \& Blanket 2. Naked - Clothing \& Blanket - Naked \& Blanket 3. Naked \& Blanket - Naked - Clothing \& Blanket 4. Naked \& Blanket - Clothing \& Blanket - Naked 5. Clothing \& Blanket - Naked - Naked \& Blanket 6. Clothing \& Blanket - Naked \& Blanket - Naked

Treatment:

Device: Feeling Hot sensor system