TRIP-Patch: Transdermal Rigidity Assessment Via Ischemia of the Penis vs the Rigiscan. A New Sensor-driven Device to Measure Rigidity of the Penis.

Sponsor

St. Antonius Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05219071

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction

Detailed 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 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.

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 we have measured night time erections with the Rigiscan in 10 patients, the study is complete.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

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.

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Outcome Measures

Primary Outcome Measures

lower saturation [1 night]
lower saturation of corpora cavernosa during an erection
temperature increase [1 night]
increase in penile skin temperature during an erection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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