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

Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Diagnostic test: Feeling Hot sensor

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Hille Torenvlied, MSc.; Phone Number: +31883202500; Email: h.torenvlied@antoniusziekenhuis.nl

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • St. Antonius Ziekenhuis
      • Contact: Hille Torenvlied, MSc; Phone Number: +31883202500; Email: h.torenvlied@antoniusziekenhuis.nl
      • Sub-Investigator: Karlijn van Adrichem, BSc.
      • Principal Investigator: Jack Beck, dr., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Age 55 - 60 years	Diagnostic test: Feeling Hot sensor; The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.
Group 2; Age 60 - 65 years	Diagnostic test: Feeling Hot sensor; The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.
Group 3; Age 65 - 70 years	Diagnostic test: Feeling Hot sensor; The Feeling Hot sensor is a proof-of-concept system, which can measure overnight penile, thigh and air temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	age, BMI, surgeries, comorbidities (diabetes, hypertension, hyperlipidemia), medication, status of smoking and alcohol consumption	1 year

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Jack Beck, dr., MD, Urologist

Study record dates

Study Major Dates

• Study Start (Anticipated): January 18, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): October 10, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Nocturnal erection; RigiScan; Penile temperature
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: ABR: 82813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No