In men without erectile problems, night time erections occur during the REM-sleep. For this study we will compare the current diagnostic test, the Rigiscan, with the data from de TRIP-Patch during the night. To validate discriminating sensor-…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
- Penile and scrotal disorders (excl infections and inflammations)
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measure saturation and desaturation in the cavernosal tissue with the
TRIP-PATCH and measuring erections with the Rigiscan.
Secondary outcome
Measure temperature of the skin of the penis and the thigh. Demographic data
including age, BMI, skin pigmentation on the penis, partner status,
comorbidities, surgeries, medications and endothelial risk factors (diabetes,
smoking, hypertension, hyperlipidemia, depression) are recorded. IEFF-5
questionnaire is taken.
Background summary
Erectile dysfunction (ED) is defined as the persistent or recurrent inability
to attain and maintain an erection sufficient to perform sexual
activity.{Zou2019} ED has an effect on physical and psychosocial well-being.
The current diagnostic test, the Rigiscan to measure night time erections, has
a lot of disadvantages.
When an erection occurs and there is no inflow and outflow in the corpora
cavernosa we expect the saturation to drop. As known with low flow priapism.
From a study from Solnick we know that the mean skin temperature in younger
male (19-33 years old) increases from 33,8°C to 36.2°C during arousal.{Solnick
1977} We developed a penile oximeter and temperature sensor, to measure
saturation and temperature of the penis during the night. The TRIP-Patch
(Transdermal Rigidity assessment via Ischemia of the Penis) is expected to
continuously measure saturation levels in the corpora cavernosa by real time
monitoring with a photodiodes and LEDs and the sensor has a temperature logger.
Study objective
In men without erectile problems, night time erections occur during the
REM-sleep. For this study we will compare the current diagnostic test, the
Rigiscan, with the data from de TRIP-Patch during the night. To validate
discriminating sensor-readings between flaccid state and full rigidity of the
penis. Eventually, to have a validated device, a patch in the size of a postage
stamp, that easily measures erectile function at home. Furthermore the
temperature on the outside of the thigh will be measured.
Study design
Observational study
Study burden and risks
Patients get a phone call at least 5 days after their appointment with a
research nurse to hear if they have questions and are willing to participate in
the study. After this call, the visit will be planned. There will not be any
risk in participating in the study.
albrecht thaerlaan 9
Utrecht 3571ea
NL
albrecht thaerlaan 9
Utrecht 3571ea
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers without (a history of) erectile dysfunction
Signed informed consent
Male
Between 18-40 year
Exclusion criteria
Volunteers who are unwilling to sign written informed consent
Volunteers with sickle cell anemia because this could affect the accuracy of
the measurements
Volunteers with erectile dysfunction
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 |
|---|---|
| Other | clinicalTrials.gov nummer volgt nog |
| CCMO | NL75891.100.21 |