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

Erectile Dysfunction Clinical Trial

— MENDiP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05578157
• Other study ID #: ABR: 82813
• Status: Not yet recruiting
• Start date: January 18, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2022
• Source: St. Antonius Hospital
• Contact: Hille Torenvlied, MSc.
• Phone: +31883202500
• Email: h.torenvlied[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

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Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: October 10, 2023
• Est. primary completion date: June 30, 2023
• Gender: Male
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

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

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic data	age, BMI, surgeries, comorbidities (diabetes, hypertension, hyperlipidemia), medication, status of smoking and alcohol consumption	1 year
Primary	Detectability absence nocturnal erections	Visual detectability of the presence and absence of nocturnal erections in overnight penile temperature measurements	9 hours
Primary	Penile temperature REM-sleep	Maximal variation in penile temperature during REM-sleep in case of presence and absence of nocturnal erections	9 hours
Primary	Penile temperature nocturnal erection	Maximal variation in penile temperature during nocturnal erections in men aged 55 - 70 years	9 hours