Erectile Dysfunction Clinical Trial
Official title:
Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and
improve impaired organ function. HBOT was also recently suggested as a possible therapy for
ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not
been investigated to date.
The objective in this study was to assess the effect of HBOT on patients with ED by means of
sexual function questionnaires and novel imaging techniques.
A prospective analysis of men, age 18 years or older, with a clinical diagnosis of erectile
dysfunction, reporting decreased and weakened nocturnal penile tumescence of six months
duration or longer.
Patients were treated at The treatment comprised 40 daily hyperbaric sessions, 5 days a
week, in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session consisted of
90 minutes of exposure to 100% oxygen at 2 ATA with 5 minutes air breaks every 30 minutes
and 1 meter per minute compression and decompression.
Sexual function Efficacy of the treatment was assessed using the International Index of
Erectile Function (IIEF) questionnaire which was filled by all patients at baseline and
within 2 weeks of the last HBOT session. In addition, assessing efficacy was the global
efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of
yes or no.
Six patients underwent two MRI scans 1-2 weeks prior to and after HBOT. Imaging was
conducted in using a 3Tesla system (MAGNETOM Skyra, Siemens Medical Solutions, , Germany).
The MRI protocol included anatomic T1 and T2 sequences and DCE. The MRI DCE sequence
parameters are detailed in supplementary section.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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