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

Sponsor
St. Antonius Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05183581
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
2.3
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Feeling Hot sensor system
 N/A

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Feeling Hot 1: Investigating the Influence of Clothing and Blankets on Penile Skin Temperature During Male Sexual Arousal
Actual Study Start Date :
May 17, 2022
Actual Primary Completion Date :
Jun 9, 2022
Actual Study Completion Date :
Jul 27, 2022

Arms and Interventions

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

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

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.

Outcome Measures

Primary Outcome Measures

  1. Temperature increase [10 minutes]

    Increase in penile skin temperature during erection

  2. (De)tumescence duration [10 minutes]

    Duration of increased penile skin temperature during erection

Secondary Outcome Measures

  1. Difference between sexual and nocturnal erections [10 hours]

    Penile and outer thigh temperature increase difference between sexual and nocturnal erection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Antonius Ziekenhuis Nieuwegein Utrecht Netherlands 3435 CM

Sponsors and Collaborators

  • St. Antonius Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hille Torenvlied, Coordinating Investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT05183581
Other Study ID Numbers:
  • 79920
First Posted:
Jan 10, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Hille Torenvlied, Coordinating Investigator, St. Antonius Hospital
Erectile Dysfunction
RigiScan
Nocturnal erection
Penile temperature
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Aug 3, 2022