NCT02619383

HBOT Application in Erectile Dysfunction

Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Erectile Dysfunction
• Hyperbaric Oxygen Therapy

Interventions

Type	Name	Description
DEVICE	Hyperbaric oxygen therapy	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-05-01
• First posted: 2015-12-02
• Last updated: 2015-12-03

Locations

1 site across 1 country: Israel