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.

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. - TRIP-Patch vs the Rigiscan

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52224

Enrollment

Registered

2021-04-15

Start date

2022-06-20

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction erection problems

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers without (a history of) erectile dysfunction Signed informed consent Male Between 18-40 year

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Measure saturation and desaturation in the cavernosal tissue with the TRIP-PATCH and measuring erections with the Rigiscan.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results