Erectile DysfunctionPhase 3LI-ESWTNCT01317680
Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)
A Phase 3 study testing Omnispec model 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 (damage that can occur after radical prostatectomy… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Omnispec model ED1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Dec 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior prostatectomy surgery
- ED of more than 6 months
- Rigidity score < 3 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
Who cannot join
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Radiotherapy in pelvic region
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Ilan Gruenwald, MD, 00972-4-8542882, i_gruenwald@rambam.health.gov.il
Yoram Vardi, Prof
About this study
Official title: Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)
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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).
- Conditions
- Erectile Dysfunction
- Being tested
- Omnispec model ED1000, Sham control
- Keywords
- Erectile Dysfunction, ED, PDE5 inhibitors, LI-ESWT
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnispec model ED1000Device
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Sham controlDevice
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
| Study group | Role | What they receive |
|---|---|---|
| Treatment LI-ESWT | Active comparator | Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites. Receives: Device: Omnispec model ED1000 |
| Sham control | Placebo comparator | We use the same probe that induces the same sensation on the penis and the same noise yet no energy. Receives: Device: Sham control |
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 posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionDec 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, i_gruenwald, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317680
- Sponsor's protocol ID
- 0037-11-RMB
- Acronym
- LI-ESWT
- Status last verified
- May 2012
- First submitted
- 8 Mar 2011
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)
- ClinicalTrials.gov ID
- NCT01317680
- Acronym / sponsor ID
- LI-ESWT / 0037-11-RMB
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, ED, PDE5 inhibitors, LI-ESWT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Mar 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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment LI-ESWT | Active comparator | Device: Omnispec model ED1000Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites. |
| Sham control | Placebo comparator | Device: Sham controlWe use the same probe that induces the same sensation on the penis and the same noise yet no energy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior prostatectomy surgery
- ED of more than 6 months
- Rigidity score < 3 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
Key exclusion criteria (4 listed)
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Radiotherapy in pelvic region
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 |
|---|---|---|
| Omnispec model ED1000Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites. | Device | Treatment LI-ESWT |
| Sham controlWe use the same probe that induces the same sensation on the penis and the same noise yet no energy | Device | Sham control |
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 24 May 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.
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 Omnispec model 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 4 inclusion and 4 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 24 May 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 24 May 2012; AzTrials last refreshed its copy on 3 Nov 2026.