Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- St. Antonius Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Temperature increase
Study Overview
Brief Summary
The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. Simultaneous measurements with the RigiScan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for erectile dysfunction diagnostics.
Detailed Description
Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunction diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteer without (a history of) erectile dysfunction
- •Aged 18 - 29 years
Exclusion Criteria
- •Test subjects who are unwilling to sign informed consent
- •Test subjects with erectile dysfunction
- •IIEF-5 score of below 17
- •(History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
- •(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.
Arms & Interventions
Nocturnal erection measurement
Overnight measurements of the temperature of the penile skin and outer thigh will be performed, while simultaneously the penile circumference and rigidity is determined by RigiScan measurements
Intervention: Feeling Hot sensor system (Device)
Outcomes
Primary Outcomes
Temperature increase
Time Frame: 8 hours
Increase in penile skin temperature during nocturnal erection
(De)tumescence duration
Time Frame: 8 hours
Duration of increased penile skin temperature during erection
Secondary Outcomes
- Difference between sexual and nocturnal erections(8 hours)
Investigators
Hille Torenvlied
Coordinating Investigator
St. Antonius Hospital