Feasibility of penile erection detection through measurements of light reflection of hemoglobin of the penis

Abstract

Timely and accurate diagnosis of erectile dysfunction (ED) is crucial for effective treatment and early detection of health risks. There is a need for a non-invasive sensor for erection detection. This study aims to investigate the feasibility of penile erection detection through measurements of light reflection of hemoglobin (LRH) of the penis. A penile LRH sensor was developed to measure changes in hemoglobin levels of the flaccid and erected penis as a precursor to the development of a SpO2-sensor. Outcomes from penile duplex and LRH measurements in ED patients were compared in the flaccid state as well as during an erection caused by intrave-nous injection of alprostadil. Results of ten patients getting a full erection are con-sidered. The results show a difference in LRH values during erections measured on the penis compared to a flaccid penis. This is the first human pilot study to demon-strate a higher LRH during the onset of an artificially induced erection in patients with ED, this tendency should be analyzed in larger studies. This is a promising ad-vancement towards the further development of a much-needed non-invasive sensor that has the potential to revolutionize the diagnosis and management of ED.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06402097

Funding Statement

This research received no external funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

the ethical committee of the Medical Research Ethics Committees United Nieuwe-gein, the Netherlands and the boards of all participating centers and it conforms to the provisions of the Declaration of Helsinki. (Registration numbers: NL70945.100.19, R19.074 approved on 17-2-2020).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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