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Completed

NCT Number: NCT02619383

HBOT Application in Erectile Dysfunction

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Hyperbaric Oxygen Therapy Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperbaric oxygen therapy

Device

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.

Other names: HBOT

Primary outcomes

  1. Sexual function

    Time frame: 3 months

    Efficacy of the treatment was assessed using the International Index of Erectile Function (IIEF) questionnaire. Primary outcome was measured by questions 3 and 4 (Q3 and Q4). Question 3 asks 'Over the past four weeks, when you have attempted sexual intercourse how often were you able to penetrate (enter) your partner?'. Question 4 asks 'Over the past four weeks, during sexual intercourse, how often were you able to maintain your erection after you have penetrated your partner?'

  2. Sexual function

    Time frame: 3 months

    global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.

Secondary outcomes

  1. Imaging of penile perfusion

    Time frame: 3 months

    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.

    K-trans calculations were performed in four specific axial sections located in each CC at the level of the penis base for better localization and reduced variability (Figure-1). Another control K-trans measurement was performed at the psoas muscle at the point in pass at the groin. The relative change in penile K-trans values (in %) was calculated as (post HBOT value - pre HBOT value) / pre HBOT value * 100.

    MRI includes Gadolinium contrast injection which has allergy related issues.

  2. Adverse events

    Time frame: 3 months

    Rate of adverse events

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis

Acronym: HBOTED

Important dates

Study start
2013
Primary completion
2015
First posted
Dec 2, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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