Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Feeling Hot sensor system
Sponsored by
About this trial
This is an interventional diagnostic trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, RigiScan, Nocturnal erection, Penile temperature
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteer without (a history of) erectile dysfunction
- Male
- 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.
Sites / Locations
- Hille Torenvlied
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nocturnal erection measurement
Arm Description
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
Outcomes
Primary Outcome Measures
Temperature increase
Increase in penile skin temperature during nocturnal erection
(De)tumescence duration
Duration of increased penile skin temperature during erection
Secondary Outcome Measures
Difference between sexual and nocturnal erections
Penile and outer thigh temperature increase difference between sexual and nocturnal erection
Full Information
NCT ID
NCT05183620
First Posted
December 22, 2021
Last Updated
August 2, 2022
Sponsor
St. Antonius Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05183620
Brief Title
Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Official Title
Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, RigiScan, Nocturnal erection, Penile temperature
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nocturnal erection measurement
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Feeling Hot sensor system
Intervention Description
The Feeling Hot sensor system consists of two temperature probes placed on the penis and the outer thigh of the test subject to measure skin temperature during erection
Primary Outcome Measure Information:
Title
Temperature increase
Description
Increase in penile skin temperature during nocturnal erection
Time Frame
8 hours
Title
(De)tumescence duration
Description
Duration of increased penile skin temperature during erection
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Difference between sexual and nocturnal erections
Description
Penile and outer thigh temperature increase difference between sexual and nocturnal erection
Time Frame
8 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteer without (a history of) erectile dysfunction
Male
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Beck, Dr.,MD.
Organizational Affiliation
Urologist, St. Antonius Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hille Torenvlied
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
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