MENDiP: Measurements of overnight penile temperature to Evaluate Nocturnal erection Detection in patients with absence of erectile functioning after robot-assisted radical Prostatectomy

Recruiting

Conditions: Erectile dysfunction
erection dysfunction
10013355

Registration Number: NL-OMON51631

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative measurement:<br /><br>1. Visual detectability of the presence and absence of nocturnal erections in<br /><br>overnight penile temperature measurements<br /><br>2. Maximal variation in penile temperature during REM-sleep in case of absence<br /><br>of nocturnal erections<br /><br><br /><br>Preoperative measurement:<br /><br>1. Maximal variation in penile temperature during REM-sleep in case of presence<br /><br>of nocturnal erections in men aged 55 - 70 years<br /><br>2. Maximal variation in penile temperature during nocturnal erections in men<br /><br>aged 55 - 70 years </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Demographic data including age, BMI, surgeries, comorbidities (diabetes,<br /><br>hypertension, hyperlipidemia, sicklecell anaemia, atherosclerosis, restless<br /><br>legs syndrome, insomnia, sleep apnea), medication and status of smoking are<br /><br>recorded. This ensures inclusion of the right patient population. Furthermore,<br /><br>patients will be asked to fill in the IIEF-5 questionnaire before and after<br /><br>surgery, which follows RARP protocol. </p><br>