Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

St. Antonius Hospital

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Feeling Hot sensor system

Study type: Interventional

Funder types: Other

Identifiers

NCT05183620

79969

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 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.

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Enrollment: 10 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer without (a history of) erectile dysfunction
• Male
• Aged 18 - 29 years

Exclusion criteria

• Test subjects who are unwilling to sign informed consent
• Test subjects with erectile dysfunction
• IIEF-5 score of below 17
• (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
• (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
• Usage of sleeping pills or benzodiazepines.

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

Nocturnal erection measurement

Other group

Description:

Overnight measurements of the temperature of the penile skin and outer thigh will be performed, while simultaneously the penile circumference and rigidity is determined by RigiScan measurements

Treatment:

Device: Feeling Hot sensor system