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

August 2, 2022 updated by: Hille Torenvlied, St. Antonius Hospital

Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Visually aroused erection (naked, clothing, blankets)

Randomisation of the order of visually aroused erection will be conducted:

  1. Naked - Naked & Blanket - Clothing & Blanket
  2. Naked - Clothing & Blanket - Naked & Blanket
  3. Naked & Blanket - Naked - Clothing & Blanket
  4. Naked & Blanket - Clothing & Blanket - Naked
  5. Clothing & Blanket - Naked - Naked & Blanket
  6. Clothing & Blanket - Naked & Blanket - Naked
Device: Feeling Hot sensor system
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature increase
Time Frame: 10 minutes
Increase in penile skin temperature during erection
10 minutes
(De)tumescence duration
Time Frame: 10 minutes
Duration of increased penile skin temperature during erection
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between sexual and nocturnal erections
Time Frame: 10 hours
Penile and outer thigh temperature increase difference between sexual and nocturnal erection
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Jack Beck, Dr.,MD., Urologist, St. Antonius Ziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Actual)

June 9, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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