Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy
Conditions
Keywords
Erectile Dysfunction, Nocturnal erection, RigiScan, Penile temperature
Brief summary
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.
Interventions
DIAGNOSTIC_TESTFeeling Hot sensor
The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.
Sponsors
St. Antonius Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
55 Years to 70 Years
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 pre-operative 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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detectability absence nocturnal erections | 9 hours | Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements |
| Penile temperature REM-sleep | 9 hours | Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections |
| Penile temperature nocturnal erection | 9 hours | Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic data | 1 year | age, BMI, surgeries, comorbidities (diabetes, hypertension, hyperlipidemia), medication, status of smoking and alcohol consumption |
Countries
Netherlands
Contacts
Primary ContactHille Torenvlied, MSc.
Outcome results
None listed