Erectile DysfunctionPhase 3NCT01442077
Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms
A Phase 3 study testing Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2013
- Phase
- Phase 3
- 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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED for more than six months in duration.
- At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different days.
- Previous positive experience with PDE5iswithin the past six months.
- A minimum of two sexual attempts per month.
- An IIEF-ED domain score of ≥19, post screening PDE5i intake.
- An IIEF-ED domain score of ≥17 and a Rigidity score ≥ 3 , post screening with PDE5i intake
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- A Rigidity score ≥ 3 post screening PDE5i intake.
- A stable heterosexual relationship with the same partner for more than three months.
- Delta IIEF-ED domain score ≤5 points on visit 1 (after 1 month wash out) compared to the IIEF-ED domain score on screening.
Who cannot join
- Prior prostate surgery.
- Any cause of ED other than of vascular etiology.
- Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities including Peyrone's disease.
- Clinically significant chronic hematological disease.
- Cardiovascular conditions that prevent sexual activity.
- History of heart attack, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study.
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- Cancer within the past five years.
- Use of anti-androgens, or oral or injectable androgens
- Use of any other treatments for ED that includes oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories within seven days of screening.
- Hormonal, neurologic, or psychological pathology.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Yoram Vardi, Prof., 00972-4-8542819, yvardi@rambam.health.gov.il
Ilan Gruenwald, MD, 00972-4-8542882, i_gruenwald@rambam.health.gov.il
About this study
Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.
Read the detailed description
At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form, and will be asked about general medical condition and any problems related to sexual dysfunction. Than the patient's sexual function will be assessed by sexual function questionnaires. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. During the visit, the patient will be assigned to one arm of the study (random), and by the arm he belongs he will receive an explanation about this procedure. Then shall obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), then it would be the first visit. At the first visit (Visit 1) The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of the visit 1 the patient will begin treatment series and will continue to study under the arm belongs, as described: 1.Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). 2.Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. 3.Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). 4.Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
Four weeks after the treatment series ends the patient will come for another visit will be asked to fill in questionnaires and perform the FMD test again.
- Conditions
- Erectile Dysfunction
- Being tested
- Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
- 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 Therapy Generator (Omnispec ED1000)Device
Also called No other names
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Device
Also called No other names
Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.
Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Device
Also called No other names
Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).
Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Device
Also called No other names
Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Active comparator | Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments. Receives: Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) |
| arm 2 | Active comparator | Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. Receives: Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) |
| arm 3 | Active comparator | Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). Receives: Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) |
| arm 4 | Active comparator | Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments). Receives: Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
Measured: 3 months
Secondary outcomes (1)
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success
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 posted28 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram Vardi, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442077
- Sponsor's protocol ID
- 0359-11-RMB
- Status last verified
- Jan 2012
- First submitted
- 26 Sep 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms
- ClinicalTrials.gov ID
- NCT01442077
- Acronym / sponsor ID
- 0359-11-RMB
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 28 Sep 2011 (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 shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.
Detailed description
At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form, and will be asked about general medical condition and any problems related to sexual dysfunction. Than the patient's sexual function will be assessed by sexual function questionnaires. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. During the visit, the patient will be assigned to one arm of the study (random), and by the arm he belongs he will receive an explanation about this procedure. Then shall obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), then it would be the first visit. At the first visit (Visit 1) The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of the visit 1 the patient will begin treatment series and will continue to study under the arm belongs, as described: 1.Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). 2.Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. 3.Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). 4.Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
Four weeks after the treatment series ends the patient will come for another visit will be asked to fill in questionnaires and perform the FMD test again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Active comparator | Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments. |
| arm 2 | Active comparator | Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. |
| arm 3 | Active comparator | Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). |
| arm 4 | Active comparator | Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ED for more than six months in duration.
- At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different days.
- Previous positive experience with PDE5iswithin the past six months.
- A minimum of two sexual attempts per month.
- An IIEF-ED domain score of ≥19, post screening PDE5i intake.
Key exclusion criteria (10 listed)
- Prior prostate surgery.
- Any cause of ED other than of vascular etiology.
- Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities including Peyrone's disease.
- Clinically significant chronic hematological disease.
- Cardiovascular conditions that prevent sexual activity.
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 Therapy Generator (Omnispec ED1000)Also: No other namesSeries of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). | Device | arm 1, arm 2, arm 3, arm 4 |
| Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Also: No other namesSeries of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. | Device | arm 2 |
| Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Also: No other namesSeries of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). | Device | arm 3 |
| Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)Also: No other namesSeries of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments). | Device | arm 4 |
Primary outcome
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
Time frame: 3 months
1 secondary outcome
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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, Prof. 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 3 study testing Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) in people with Erectile Dysfunction, run by Rambam Health Care Campus 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 9 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: status not confirmed, as of the sponsor's last update on 18 Jan 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoram Vardi, Prof. (00972-4-8542819, yvardi@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success (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 18 Jan 2012.