The objective of the Feeling Hot 2 study is to determine the change in penile skin temperature during nocturnal erections, which will be detected by the RigiScan. Furthermore, the effect of nocturnal erections on the outer thigh skin temperature is…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
- Penile and scrotal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the Feeling Hot 2 study is to determine the change in
penile skin temperature and increased duration of (de)tumescence during
nocturnal erections. With these outcomes, the validity of temperature
measurements to detect nocturnal erections can be determined.
Secondary outcome
Secondary outcome of the Feeling Hot 2 study combines the results of the
Feeling Hot 1 study. It is studied what differences in bodily skin temperature
exist between nocturnal erections and visually aroused erections. Furthermore,
it is studied whether the reference temperature probe placed on the outer thigh
can compensate for the environmental influences of blankets and clothing.
Background summary
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 The RigiScan uses outdated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, 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 in the search of modernizing erectile dysfunction
diagnostics.
Study objective
The objective of the Feeling Hot 2 study is to determine the change in penile
skin temperature during nocturnal erections, which will be detected by the
RigiScan. Furthermore, the effect of nocturnal erections on the outer thigh
skin temperature is determined.
Study design
The Feeling Hot 2 study is an observational study with a cross-sectional
design.
Study burden and risks
The burden for the volunteers will be two visits to the hospital and an
overnight measurement at home. Hopsital visits will last approximately 30
minutes. There is no risk associated with participation and usage of the
temperature sensors. There is no direct benefit for the healthy volunteers for
participating, but the outcomes will help improve ED diagnostics.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05183620 |
| CCMO | NL79969.100.21 |