Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

Sponsor

St. Antonius Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05183620

Collaborator

(none)

Enrollment

Location

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 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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 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

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Feeling Hot 2: Evaluating Nocturnal Erection Detection With Penile Temperature Measurements in the Search of a Modern Erectile Dysfunction Diagnostic Tool

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: 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	Device: Feeling Hot sensor system 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

Arm

Intervention/Treatment

Other: 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

Device: Feeling Hot sensor system

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

Outcome Measures

Primary Outcome Measures

Temperature increase [8 hours]
Increase in penile skin temperature during nocturnal erection
(De)tumescence duration [8 hours]
Duration of increased penile skin temperature during erection

Secondary Outcome Measures

Difference between sexual and nocturnal erections [8 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hille Torenvlied	Nieuwegein		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:

NCT05183620

Other Study ID Numbers:

79969

First Posted:

Jan 10, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hille Torenvlied, Coordinating Investigator, St. Antonius Hospital

Additional relevant MeSH terms:

Erectile Dysfunction

Study Results

No Results Posted as of Aug 3, 2022