HBOT Application in Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— HBOTED  

Official title:

Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619383
• Other study ID #: 42/13
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2015
• Last updated: December 2, 2015
• Start date: June 2013

Study information

• Verified date: December 2015
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hyperbaric Oxygen Therapy

Intervention

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.

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual function	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?'	3 months	No
Primary	Sexual function	global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.	3 months	No
Secondary	Imaging of penile perfusion	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.	3 months	Yes
Secondary	Adverse events	Rate of adverse events	3 months	Yes