HBOTED: HBOT Application in Erectile Dysfunction

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02619383
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction; Hyperbaric Oxygen Therapy	Device: Hyperbaric oxygen therapy	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HBOT 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.	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.; Other Names: HBOT

Outcome Measures

Primary Outcome Measures

1. Sexual function [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 [3 months]

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

Secondary Outcome Measures

1. Imaging of penile perfusion [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 [3 months]

   Rate of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assaf-Harofeh Medical Center	Zerifin		Israel	70300

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assaf Harofeh MC, Dr. Shai Efrati, Assaf-Harofeh Medical Center
• ClinicalTrials.gov Identifier: NCT02619383
• Other Study ID Numbers: 42/13
• First Posted: Dec 2, 2015
• Last Update Posted: Dec 3, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Assaf Harofeh MC, Dr. Shai Efrati, Assaf-Harofeh Medical Center: HBOT; hyperbaric oxygen; DCE; ED; erectile dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Dec 3, 2015