Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

Not Applicable

Completed

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

• Registration Number: NCT05183620
• 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 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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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.

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nocturnal erection measurement	Feeling Hot sensor system	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

Primary Outcome Measures

Name	Time	Method
Temperature increase	8 hours	Increase in penile skin temperature during nocturnal erection
(De)tumescence duration	8 hours	Duration of increased penile skin temperature during erection

Secondary Outcome Measures

Name	Time	Method
Difference between sexual and nocturnal erections	8 hours	Penile and outer thigh temperature increase difference between sexual and nocturnal erection

Trial Locations

Locations (1)

Hille Torenvlied; 🇳🇱 Nieuwegein, Netherlands