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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: Feeling Hot sensor system

• Registration Number: NCT05183581
• Lead Sponsor: St. Antonius Hospital

Brief 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 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.

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-10
• Study Start: 2022-05-17
• Primary Completion: 2022-06-09
• Study Completion: 2022-07-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visually aroused erection (naked, clothing, blankets)	Feeling Hot sensor system	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

Primary Outcome Measures

Name	Time	Method
(De)tumescence duration	10 minutes	Duration of increased penile skin temperature during erection
Temperature increase	10 minutes	Increase in penile skin temperature during erection

Secondary Outcome Measures

Name	Time	Method
Difference between sexual and nocturnal erections	10 hours	Penile and outer thigh temperature increase difference between sexual and nocturnal erection

Trial Locations

Locations (1)

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Utrecht, Netherlands