Transdermal Rigidity assessment via Ischemia of the Penis (TRIP). A new sensor-driven device to measure maximal rigidity.

*Transdermal Rigidity assessment via Ischemia of the Penis (TRIP). A new sensor-driven device to measure maximal rigidity.* - TRIP-patch

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48500

Enrollment

Registered

2020-02-17

Start date

2020-06-05

Completion date

Unknown

Last updated

2024-04-15

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 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients who are unwilling to sign written informed consent - Patients unable to undergo a duplex of the penis - Patients with sickle cell anemia because this could affect the accuracy of the measurements

Design outcomes

Primary

Measure	Time frame
Duplex: Duplex ultrasound of the penis (Hitachi Aloka V60 penile probe L55 13-5) is used to obtain ultrasound images and vascular data of the corpora cavernosa. Interpretation of the data is done by a urologist and a nurse who are specialized in ultrasounds and duplex examinations of the penis. TRIP-Patch: The oximeter sensor is proposed to measure the saturation level in the corpora cavernosa by real time monitoring with a photodiodes and LEDs. Raw-data of the saturation of the penis before and during an erection is harvested. The data are converted to Excel (send to the investigators computer via bluetooth). The sensor settings tests are based on the information from the sensor description of the functionality options. Part one: Identifying the best locations for the sensor. Ten patients with full rigidity after 20uG alprostadil are included for testing the optimal location of the sensor in flaccid state and full rigidity. In our experience with duplex scans and reactions on alprostadil, we expect to examine approximately fifteen patients, to include and measure ten patients with a full rigidity. Before erection, the sensor is placed on four different sites (two proximal and two distal on 2 and 10 oclock) on the dorsal penis to identify possible differences in measurement. After intracavernosal injection, before full rigidity is obtained, the duplex of the penis will be executed. During full rigidity the sensors are placed again on the same 4 places of the penis to test the most accurate localization for the sensor. With the information of the duplex the urologist will differentiate between ischemic and non-ischemic measurements. Part two: Measuring desaturation of the cavernosal tissue during full rigidity with different sensor settings Twenty patients with a full rigidity after injection with 20uG alprostadil are included to test and validate the sensor. In our experience with duplex scans and reactions on alprostadil,	—

Measure

Time frame

Duplex: Duplex ultrasound of the penis (Hitachi Aloka V60 penile probe L55 13-5) is used to obtain ultrasound images and vascular data of the corpora cavernosa. Interpretation of the data is done by a urologist and a nurse who are specialized in ultrasounds and duplex examinations of the penis. TRIP-Patch: The oximeter sensor is proposed to measure the saturation level in the corpora cavernosa by real time monitoring with a photodiodes and LEDs. Raw-data of the saturation of the penis before and during an erection is harvested. The data are converted to Excel (send to the investigator*s computer via bluetooth). The sensor settings tests are based on the information from the sensor description of the functionality options. Part one: Identifying the best locations for the sensor. Ten patients with full rigidity after 20uG alprostadil are included for testing the optimal location of the sensor in flaccid state and full rigidity. In our experience with duplex scans and reactions on alprostadil, we expect to examine approximately fifteen patients, to include and measure ten patients with a full rigidity. Before erection, the sensor is placed on four different sites (two proximal and two distal on 2 and 10 o*clock) on the dorsal penis to identify possible differences in measurement. After intracavernosal injection, before full rigidity is obtained, the duplex of the penis will be executed. During full rigidity the sensors are placed again on the same 4 places of the penis to test the most accurate localization for the sensor. With the information of the duplex the urologist will differentiate between ischemic and non-ischemic measurements. Part two: Measuring desaturation of the cavernosal tissue during full rigidity with different sensor settings Twenty patients with a full rigidity after injection with 20uG alprostadil are included to test and validate the sensor. In our experience with duplex scans and reactions on alprostadil,

—

Secondary

Measure	Time frame
Demographic data including age, BMI, race(skin pigmentation), 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