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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 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-10-13

No results posted yet for this study

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Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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

Conditions

Interventions

DIAGNOSTIC_TEST

Feeling Hot sensor

The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Jack Beck, dr., MD · Urologist

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2023-06-30
Completion
2023-10-10

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05578157 on ClinicalTrials.gov