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

Erectile Dysfunction Clinical Trial

Official title:

Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183581
• Other study ID #: 79920
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2022
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 27, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Feeling Hot sensor system
The Feeling Hot sensor system consists of two temperature probes placed on the penis and outer thigh of the test subject to measure skin temperature during erection.

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature increase	Increase in penile skin temperature during erection	10 minutes
Primary	(De)tumescence duration	Duration of increased penile skin temperature during erection	10 minutes
Secondary	Difference between sexual and nocturnal erections	Penile and outer thigh temperature increase difference between sexual and nocturnal erection	10 hours