Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, RigiScan, Nocturnal erection, Penile temperature
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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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.
Interventions
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
Sponsors
St. Antonius Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Difference between sexual and nocturnal erections | 8 hours | Penile and outer thigh temperature increase difference between sexual and nocturnal erection |
Countries
Netherlands
Outcome results
None listed