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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05578157
Other study ID # ABR: 82813
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation.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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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