TRIP-Patch vs the Rigiscan

Erectile Dysfunction Clinical Trial

— TRIP-Patch  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219071
• Other study ID #: 75891
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: September 14, 2022

Study information

• Verified date: November 2022
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In men without erectile problems, night time erections occur during the REM-sleep. For this study the current diagnostic test, the Rigiscan is compared, with the data from the 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.

Description:

Background of the study: Erectile dysfunction (ED) is defined as the persistent or recurrent inability to attain and maintain an erection sufficient to perform sexual activity. 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 it is expected that the saturation will drop. As known with low flow priapism. From a study from Solnick, the mean skin temperature in younger male (19-33 years old) increases from 33,8°C to 36.2°C during arousal. A penile oximeter and temperature sensor was developed, 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.

Objective of the study: see above Study design: Observational study Study population: Healthy volunteers are asked to participate after informed consent. Age between 18 and 40 years. Both sensors and the Rigiscan will be placed at the same time, when 10 patients have night time erections with the Rigiscan, the study is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 14, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in saturation	Change in saturation of corpora cavernosa during an erection	1 night
Primary	temperature change	Change in penile skin temperature during an erection	1 night