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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05183620
Other study ID # 79969
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 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.


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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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


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: - 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Hille Torenvlied Nieuwegein

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 nocturnal erection 8 hours
Primary (De)tumescence duration Duration of increased penile skin temperature during erection 8 hours
Secondary Difference between sexual and nocturnal erections Penile and outer thigh temperature increase difference between sexual and nocturnal erection 8 hours
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