Erectile DysfunctionPhase 1HBOTEDNCT02619383
HBOT Application in Erectile Dysfunction
A Phase 1 study testing Hyperbaric oxygen therapy in people with Erectile Dysfunction and Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- clinical diagnosis of erectile dysfunction
- reporting decreased and weakened nocturnal penile tumescence of six months duration or longer
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
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.
Read the 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.
- Conditions
- Erectile Dysfunction, Hyperbaric Oxygen Therapy
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- HBOT, hyperbaric oxygen, DCE, ED, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
Also called HBOT
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.
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Experimental | 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. Receives: Device: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?'
Measured: 3 months
Sexual function
global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Adverse events
Rate of adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJun 2013
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619383
- Sponsor's protocol ID
- 42/13
- Acronym
- HBOTED
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
- ClinicalTrials.gov ID
- NCT02619383
- Acronym / sponsor ID
- HBOTED / 42/13
- Conditions
- Erectile Dysfunction, Hyperbaric Oxygen Therapy
- Keywords
- HBOT, hyperbaric oxygen, DCE, ED, erectile dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOT | Experimental | Device: Hyperbaric oxygen therapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- clinical diagnosis of erectile dysfunction
- reporting decreased and weakened nocturnal penile tumescence of six months duration or longer
Key exclusion criteria (7 listed)
- penile anatomical defects,
- any active or history of malignancy including prostate cancer
- spinal cord injury
- any major psychiatric disorder uncontrolled with treatment
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyAlso: HBOTThe 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. | Device | HBOT |
Primary outcome
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?'
Sexual function
Time frame: 3 months
global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.
2 secondary outcomes
Imaging of penile perfusion
Time frame: 3 months
Adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperbaric oxygen therapy in people with Erectile Dysfunction and Hyperbaric Oxygen Therapy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.