Erectile DysfunctionPhase 1/2NCT00901056
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
A Phase 1/2 study testing Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by Medispec at 1 site in Israel.
Trial summary
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Mar 2010
- Phase
- Phase 1/2
- 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
- ED of more than 6 months
- At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
- Positive response to PDE-5 inhibitors
- IIEF-5 domain score of 12-20 denoting mild to severe ED
- Non-Neurological pathology
- Stable heterosexual relationship for more than 3 months
Who cannot join
- NPT - normal/flat
- Prior prostatectomy surgery
- Any cause of ED other than vascular related
- Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Cardiovascular conditions that prevent sexual activity
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- History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
- Cancer within the past 5 years.
- Anti-androgens, oral or injectable androgens
- Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.
Read the detailed description
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.
- Conditions
- Erectile Dysfunction
- Being tested
- Extracorporeal Shockwave Therapy
- Keywords
- ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
Also called Vascuspec
Energy Density - 0.02 - 0.15 mJ/mm2
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Active comparator | This group will receive actual shockwave treatment Receives: Device: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF score
Measured: 3 months
Secondary outcomes (5)
Rigid Score (RS)
Measured: 3 months
Quality of Erection Questionnaire (QEQ)
Measured: 3 months
Self-Esteem And Relationship Questionnaire (SEAR)
Measured: 3 months
Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
Measured: 3 months
Side Effects
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 posted13 May 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionMar 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Investigators
- Yoram Vardi, Professor, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901056
- Sponsor's protocol ID
- ED-ESWT
- Status last verified
- Nov 2010
- First submitted
- 12 May 2009
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin
- ClinicalTrials.gov ID
- NCT00901056
- Acronym / sponsor ID
- ED-ESWT
- Conditions
- Erectile Dysfunction
- Keywords
- ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 May 2009 (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.
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.
Detailed description
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Active comparator | Device: Extracorporeal Shockwave TherapyThis group will receive actual shockwave treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ED of more than 6 months
- At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
- Positive response to PDE-5 inhibitors
- IIEF-5 domain score of 12-20 denoting mild to severe ED
- Non-Neurological pathology
Key exclusion criteria (10 listed)
- NPT - normal/flat
- Prior prostatectomy surgery
- Any cause of ED other than vascular related
- Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
- Clinically significant chronic hematological disease
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyAlso: VascuspecEnergy Density - 0.02 - 0.15 mJ/mm2 | Device | Treated Group |
Primary outcome
IIEF score
Time frame: 3 months
5 secondary outcomes
Rigid Score (RS)
Time frame: 3 months
Quality of Erection Questionnaire (QEQ)
Time frame: 3 months
Self-Esteem And Relationship Questionnaire (SEAR)
Time frame: 3 months
Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
Time frame: 3 months
Side Effects
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 25 Jan 2011.
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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.
Yoram Vardi, Professor principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by Medispec 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 6 inclusion and 10 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 25 Jan 2011. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
IIEF score (time frame: 3 months). 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 25 Jan 2011.