HBOT Application in Erectile Dysfunction (HBOTED)
Primary Purpose
Erectile Dysfunction, Hyperbaric Oxygen Therapy
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring HBOT, hyperbaric oxygen, DCE, ED, erectile dysfunction
Eligibility Criteria
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.
Sites / Locations
- Assaf-Harofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HBOT
Arm 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.
Outcomes
Primary Outcome Measures
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?'
Sexual function
global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.
Secondary Outcome Measures
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.
Adverse events
Rate of adverse events
Full Information
NCT ID
NCT02619383
First Posted
November 29, 2015
Last Updated
December 2, 2015
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02619383
Brief Title
HBOT Application in Erectile Dysfunction
Acronym
HBOTED
Official Title
Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Hyperbaric Oxygen Therapy
Keywords
HBOT, hyperbaric oxygen, DCE, ED, erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBOT
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hyperbaric oxygen therapy
Other Intervention Name(s)
HBOT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual function
Description
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?'
Time Frame
3 months
Title
Sexual function
Description
global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Imaging of penile perfusion
Description
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.
Time Frame
3 months
Title
Adverse events
Description
Rate of adverse events
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
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HBOT Application in Erectile Dysfunction
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