To measure saturation and desaturation of the cavernosal tissue with a cutaneousplaced penile sensor, before and during full rigidity. To validate discriminatingsensor-readings between flaccid state and full rigidity of the penis. To explore the…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
- Penile and scrotal disorders (excl infections and inflammations)
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, we expect to examine approximately thirty patients, to include and
measure
twenty patients with a full rigidity. The sensor is placed on the best location
as
concluded in *part one*. Sensor data is harvested before and during erection.
Sensor
setting testing: During duplex software driven sensor alterations are tested,
to obtain
best sensor raw data for analysis. The sensor is placed on the two best
locations
identified in the first part of the study. Data analysing sensor settings: Raw
data from
each site will be analysed. A mean will be calculated for each site for each
patient
before and after the erection. To examine which sensor setup differentiates the
best for
deoxygenation.(Table 6)
Secondary outcome
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.
Background summary
Erectile dysfunction (ED) is defined as the persistent or recurrent inability
to attain and
maintain an erection sufficient to perform sexual activity.{Zou2019} The
incidence rate
of ED (new cases per 1,000 men annually) was 19.2 (mean follow-up of 4.2 years)
in a
Dutch study.{Schouten2005} ED has an effect on physical and psychosocial well
being.
*ED has progressively emerged as an important sentinel marker of cardiovascular
and
overall health among men. A timely and accurate diagnosis of ED may thus
represent a
significant opportunity both to diagnose and treat the dysfunction per se and
to identify
comorbid and potentially life threatening conditions.*{Salonia2013}
Normal erection function depends on the hemodynamic interaction of cavernosal
arterial
inflow and perfusion pressure and the development of an adequate degree of
venous
outflow resistance. *Sufficient pressure in the corpora cavernosa must be
achieved and
maintained for a functional erection to occur.*{Lue1987} From patients with a
low flow
priapism we know that the saturation drops in the corpora cavernosa after some
time.
When a full erection occurs there will also be a saturation drop in the corpora
cavernosa. Abnormalities of either arterial perfusion, corporal venoclusion, or
both may
result in erectile dysfunction.{Krane1989} 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.
The pathophysiology of ED may be vasculogenic, neurogenic, anatomical, hormonal,
drug-induced and/or psychogenic.{Gratzke2010 and Hackett2018} ED is commonly
classified into three categories based on its aetiology. These include
organic(oED),
psychogenic(pED) and mixed ED (mED).{Salonia2013}
To differentiate between these kind of ED, there are specific specific
diagnostic tests.
These include the Rigiscan assessment of nocturnal penile tumescence(NPT) and
rigidity, a dynamic duplex, ultrasound penile blood flow evaluation, a dynamic
infusion
cavernosometry, cavernosography or an internal pudendal arteriography.
All these diagnostic tests that are available to evaluate the penile rigidity,
have
disadvantages. In men without erectile problems, night time erections occur
during the
REM-sleep. A measurement of an erection during nighttime in a patient with ED,
indicates a pED. And an abnormal NPT indicates oED.
Nocturnal penile monitoring is a technique used to differentiate between pED
and oED.
A Rigiscan is mostly used for this purpose. It can confirm normal erectile
potency,
frequency, quality, duration, but still has a lot of disadvantages (for
instance, sleep
disturbances).{Zou2019},{Qin2018}. Some other disadvantages of the Rigiscan are:
expired CE-approvement and the software isn*t compatible with current operating
systems. In this era of sensors and smartphone applications, we foresee a need
for a
*smart device* in the size of a postage stamp, to measure (nocturnal) erectile
function at
home, easily explained in a smartphone application. A penile oximeter sensor
will be
tested to measure desaturation of the penis during full rigidity. The TRIP-Patch
(Transdermal Rigidity assessment via Ischemia of the Penis) is expected to
continuous
measure saturation levels in the corpora cavernosa by real time monitoring with
a
photodiodes and LEDs.
Study objective
To measure saturation and desaturation of the cavernosal tissue with a cutaneous
placed penile sensor, before and during full rigidity. To validate
discriminating
sensor-readings between flaccid state and full rigidity of the penis. To
explore the best
locations on the penis for placing the sensor and to explore best sensor
software
settings for optimal sensor readings.
Eventually, to have a validated device, a patch in the size of a postage stamp,
that
easily measures erectile function at home.
Study design
Observational study: Cross sectional study
Study burden and risks
Patients get a phone call at least 5 days after their appointment with their
clinician to hear if the have questions and are willing to participate in the
study. After this call, the duplex will be planned with 20 minutes extra time.
There will not be any risk in participating in the study.
albrecht thaerlaan 9
Utrecht 3571ea
NL
albrecht thaerlaan 9
Utrecht 3571ea
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL70945.100.19 |