Erectile DysfunctionTRIP-PatchNCT05219071
TRIP-Patch vs the Rigiscan
An observational study of Erectile Dysfunction, run by St. Antonius Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jun 2022to 14 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Residents and medical students in the St Antonius Hospital and other volunteers
Who may be able to join
- Healthy volunteers without (a history of) erectile dysfunction
- Signed informed consent
- Male
- Between 18-40 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Keywords
- Rigiscan, Nocturnal erection, Temperature, Saturation
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in saturation
Change in saturation of corpora cavernosa during an erection
Measured: 1 night
temperature change
Change in penile skin temperature during an erection
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start20 Jun 2022
- Primary completion13 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Trip, St. Antonius Hospital
- Investigators
- Evelien Trip, drs, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219071
- Sponsor's protocol ID
- 75891
- Acronym
- TRIP-Patch
- Status last verified
- Nov 2022
- First submitted
- 20 Jan 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05219071
- Acronym / sponsor ID
- TRIP-Patch / 75891
- Conditions
- Erectile Dysfunction
- Keywords
- Rigiscan, Nocturnal erection, Temperature, Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents and medical students in the St Antonius Hospital and other volunteers
Key inclusion criteria (4 listed)
- Healthy volunteers without (a history of) erectile dysfunction
- Signed informed consent
- Male
- Between 18-40 year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in saturation
Time frame: 1 night
Change in saturation of corpora cavernosa during an erection
temperature change
Time frame: 1 night
Change in penile skin temperature during an erection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelien Trip, drs, MD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in saturation (time frame: 1 night). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.