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Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Feeling Hot sensor system
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, RigiScan, Nocturnal erection, Penile temperature

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male
  • Aged 18 - 29 years
  • Capable of getting visually arousable erections

Exclusion Criteria:

  • Test subject unwilling to sign informed consent
  • Test subject with erectile dysfunction
  • IIEF-5 score below 17
  • Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II

Sites / Locations

  • St. Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Visually aroused erection (naked, clothing, blankets)

Arm Description

Randomisation of the order of visually aroused erection will be conducted: Naked - Naked & Blanket - Clothing & Blanket Naked - Clothing & Blanket - Naked & Blanket Naked & Blanket - Naked - Clothing & Blanket Naked & Blanket - Clothing & Blanket - Naked Clothing & Blanket - Naked - Naked & Blanket Clothing & Blanket - Naked & Blanket - Naked

Outcomes

Primary Outcome Measures

Temperature increase
Increase in penile skin temperature during 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

First Posted
December 22, 2021
Last Updated
August 2, 2022
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05183581
Brief Title
Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis
Official Title
Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal
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
Product Manufactured in and Exported from the U.S.
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 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. Healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize 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 dysfunctions 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, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

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
Visually aroused erection (naked, clothing, blankets)
Arm Type
Other
Arm Description
Randomisation of the order of visually aroused erection will be conducted: Naked - Naked & Blanket - Clothing & Blanket Naked - Clothing & Blanket - Naked & Blanket Naked & Blanket - Naked - Clothing & Blanket Naked & Blanket - Clothing & Blanket - Naked Clothing & Blanket - Naked - Naked & Blanket Clothing & Blanket - Naked & Blanket - Naked
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 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 erection
Time Frame
10 minutes
Title
(De)tumescence duration
Description
Duration of increased penile skin temperature during erection
Time Frame
10 minutes
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
10 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: Male Aged 18 - 29 years Capable of getting visually arousable erections Exclusion Criteria: Test subject unwilling to sign informed consent Test subject with erectile dysfunction IIEF-5 score below 17 Medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type I/II
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
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis

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