Transdermal Rigidity assessment via Ischemia (and temperature) of the Penis (TRIP) versus the Rigiscan. A new sensor-driven device to measure rigidity of the penis.
Recruiting
- Conditions
- Erectile dysfunctionerection problems100404801001335510047079
- Registration Number
- NL-OMON52224
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measure saturation and desaturation in the cavernosal tissue with the<br /><br>TRIP-PATCH and measuring erections with the Rigiscan.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Measure temperature of the skin of the penis and the thigh. Demographic data<br /><br>including age, BMI, skin pigmentation on the penis, partner status,<br /><br>comorbidities, surgeries, medications and endothelial risk factors (diabetes,<br /><br>smoking, hypertension, hyperlipidemia, depression) are recorded. IEFF-5<br /><br>questionnaire is taken.</p><br>