TRIP-Patch vs the Rigiscan

NCT ID: NCT05219071

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2022-09-14

Brief 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.

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 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.

Conditions

Erectile Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Evelien Trip

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evelien Trip, drs, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

75891

Identifier Type: -

Identifier Source: org_study_id