The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. By including patients undergoing a radical prostatectomy, absence of erectile functioning is…
ID
Source
Brief title
Condition
- Penile and scrotal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative measurement:
1. Visual detectability of the presence and absence of nocturnal erections in
overnight penile temperature measurements
2. Maximal variation in penile temperature during REM-sleep in case of absence
of nocturnal erections
Preoperative measurement:
1. Maximal variation in penile temperature during REM-sleep in case of presence
of nocturnal erections in men aged 55 - 70 years
2. Maximal variation in penile temperature during nocturnal erections in men
aged 55 - 70 years
Secondary outcome
Demographic data including age, BMI, surgeries, comorbidities (diabetes,
hypertension, hyperlipidemia, sicklecell anaemia, atherosclerosis, restless
legs syndrome, insomnia, sleep apnea), medication and status of smoking are
recorded. This ensures inclusion of the right patient population. Furthermore,
patients will be asked to fill in the IIEF-5 questionnaire before and after
surgery, which follows RARP protocol.
Background summary
Erectile dysfunction (ED) occur at a high frequency and the treatment is
dependent on the cause of ED. There are two causes of ED defined: somatic
nature or psychological nature. The only available method to differentiate in
cause is by determining the presence of nocturnal erections in patients. Every
man with normal erectile functioning experiences 2 - 5 nocturnal erections each
nigh. Patients with a psychological cause of ED do have nocturnal erections as
they occur involuntarily. In case of somatic ED, resulting from for example
non-nerve-sparing prostatectomy, nocturnal erections are absent. Currently
nocturnal erection detection is performed with the "RigiScan". This device was
developed in 1985 and requires an update. Patients experience discomfort due to
the systems' large size, the system components are not manufactured anymore,
and the system runs on outdated software.
To optimize comfort for these patients, the St. Antonius Ziekenhuis studies the
feasibilit of nocturnal erection detection with penile temperature measurement.
A skin temperature sensor does not require pressure on the penile skin and is
therefore much more patient-friendly. Previous studies have found that the
penile temperature increases significantly during erection. Furthermore, it has
been found that nocturnal erections can be detected with penile temperature
measurements. However, it has not been studied whether penile temperature
measurements can also determine the absence of nocturnal erections. This is
required before the system can be clinically implemented and used in patients
with ED.
Study objective
The objective of the MENDiP-study is to determine the feasibility to detect the
absence of nocturnal erections with overnight penile temperature sensors. By
including patients undergoing a radical prostatectomy, absence of erectile
functioning is ensured, and a comparison can be made with normal erectile
functioning prior to surgery. By comparing the results of the temperature
sensor with simultaneously recorded RigiScan measurements, insight is gained in
how penile temperature measurements can be used for nocturnal erection
detection diagnostics. The sleep quality is judged on the simultaneously
recorded Fitbit measurements, which will also be used to annotate the sleep
stages during the overnight measurements. The preoperative measurements give
more insight into the effect of age on the penile temperature during nocturnal
erections in test subjects with normal erectile functioning at a higher age
compared to the Feeling Hot studies. The outcomes of this study will be used
for the development of a new sensor for nocturnal erection detection in
patients with ED.
Study design
The MENDiP study is an observational study with a longitudinal design.
Study burden and risks
The burden for the volunteers consists of two ambulatory overnight
measurements. The two appointments for information and material distribution
will either take place at the hospital or at an external location and will last
approximately 30 minutes. There is no risk associated with participation and
usage of the temperature sensors. There is no direct benefit for the healthy
volunteers for participating, but the outcomes help improve erectile
dysfunction diagnostics.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
1. Preoperative measurement:
* Aged 55 - 70 years
* Prostatecancer patients undergoing a non-/unilateral-nerve-sparing radical
prostatectomy (RARP)
* Pre-operative IIEF-5 score > 21
2. Postoperative measurement
* Inclusion criteria of preoperative measurement
* Preoperative penile temperature increase during first nocturnal erection of
minimally 0.4 degrees Celsius
* Post-operative IIEF-5 score < 12 with absence of morning erections
Exclusion criteria
* Test subjects who are unwilling to sign informed consent
* Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)
* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
These conditions might influence penile blood circulation and therefore the
accuracy of the study outcomes.
* (History of) REM-sleep behavior disorder or other sleep disorders such as
restless legs syndrome, insomnia, and sleep apnea
* Usage of sleeping pills or benzodiazepines.
* Postoperative results will be excluded from the study in case of presence of
nocturnal erections according to the RigiScan data.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05578157 |
| CCMO | NL82813.100.22 |