HBOT Application in Erectile Dysfunction
HBOTED
Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 29, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedDecember 3, 2015
December 1, 2015
1.9 years
November 29, 2015
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Sexual function
global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.
3 months
Secondary Outcomes (2)
Imaging of penile perfusion
3 months
Adverse events
3 months
Study Arms (1)
HBOT
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age 18 years or older
- clinical diagnosis of erectile dysfunction
- reporting decreased and weakened nocturnal penile tumescence of six months duration or longer
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Shai Efrati
Study Record Dates
First Submitted
November 29, 2015
First Posted
December 2, 2015
Study Start
June 1, 2013
Primary Completion
May 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12