Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

NCT ID: NCT05183620

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-07-27

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 The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock.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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Feeling Hot sensor system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hille Torenvlied

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jack Beck, Dr.,MD.

Role: PRINCIPAL_INVESTIGATOR

Urologist, St. Antonius Ziekenhuis

Locations

Hille Torenvlied

Nieuwegein, , Netherlands

Countries

Netherlands

Other Identifiers

79969

Identifier Type: -

Identifier Source: org_study_id