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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02619383
Other study ID # 42/13
Secondary ID
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. completion date
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


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
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