Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Age 55 - 60 years |
| |
| Group 2 | Age 60 - 65 years |
| |
| Group 3 | Age 65 - 70 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeling Hot sensor | Diagnostic Test | The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detectability absence nocturnal erections | Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements | 9 hours |
| Penile temperature REM-sleep | Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections | 9 hours |
| Penile temperature nocturnal erection | Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years | 9 hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | age, BMI, surgeries, comorbidities (diabetes, hypertension, hyperlipidemia), medication, status of smoking and alcohol consumption | 1 year |
Inclusion Criteria:
Preoperative measurement:
Postoperative measurement
Exclusion Criteria:
Not provided
Not provided
Not provided
Fifteen patients, aged 55 - 70 years, who will undergo a non- or unilateral-nerve-sparing robot assisted radical prostatectomy will be included in case preoperative normal erectile functioning and postoperative complete impotence at three months after surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hille Torenvlied, MSc. | Contact | +31883202500 | h.torenvlied@antoniusziekenhuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jack Beck, dr., MD | Urologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Ziekenhuis | Nieuwegein | Utrecht | 3435CM | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided