HBOT Application in Erectile Dysfunction (HBOTED)

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Completed; Phase 1

Conditions: Hyperbaric Oxygen Therapy; Erectile Dysfunction

Treatments: Device: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02619383

42/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 years or older
• clinical diagnosis of erectile dysfunction
• reporting decreased and weakened nocturnal penile tumescence of six months duration or longer

Exclusion criteria

• penile anatomical defects,
• any active or history of malignancy including prostate cancer
• spinal cord injury
• any major psychiatric disorder uncontrolled with treatment
• claustrophobia
• chronic lung disease
• chronic middle ear or sinus diseases.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

HBOT

Experimental group

Description:

All patients were treated with 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.

Treatment:

Device: Hyperbaric oxygen therapy