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MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy

NCT05578157 · St. Antonius Hospital · Updated 13 Oct 2022

What is being tested
Feeling Hot sensor
For
Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 55 years to 70 years. About 15 people. The full rules are on the registry page.
Where
Netherlands
When
Starts or started 18 Jan 2023, ends 10 Oct 2023. Registered 13 Oct 2022.
Results
None posted yet.

In the researchers' words

Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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.
ClinicalTrials.gov, NCT05578157

Sites

  • St. Antonius ZiekenhuisNieuwegein, Utrecht, Netherlands