Clinical trial NCT05578157: MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
Official title: MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Erectile Dysfunction Following Radical Prostatectomy
Keywords: Erectile Dysfunction
Nocturnal erection
RigiScan
Penile temperature
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 15
Sex: MALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detectability absence nocturnal erections
timeFrame: 9 hours
measure: Penile temperature REM-sleep
timeFrame: 9 hours
measure: Penile temperature nocturnal erection
timeFrame: 9 hours
Secondary outcomes:
Other outcomes:
measure: Demographic data
timeFrame: 1 year
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
Study officials:
affiliation: Urologist
name: Jack Beck, dr., MD
role: PRINCIPAL_INVESTIGATOR
References: