Erectile DysfunctionPhase 3LI-ESWTNCT01262157
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
A Phase 3 study testing Extracorporeal Shockwave Therapy Generator (Vascuspec) and Low intensity shock wave therapy 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 that do not respond to oral therapy (PDE-5… Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Extracorporeal Shockwave Therapy Generator (Vascuspec) and Low intensity shock wave therapy
- 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
- Apr 2010to Jan 2012
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED of more than 6 months
- Rigidity score < 3 during PDE5i therapy
- SHIM <21 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
Who cannot join
- Prior prostatectomy surgery
- 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, Israel, 31096
Yoram Vardi, Prof, ++97248542819, yvardi@rambam.health.gov.il
Ilan Gruenwald, MD
About this study
Official title: A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
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 that do not respond to oral therapy (PDE-5 inhibitors).
Read the detailed description
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.
- Conditions
- Erectile Dysfunction
- Being tested
- Extracorporeal Shockwave Therapy Generator (Vascuspec), Low intensity shock wave therapy
- Keywords
- Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.
- 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 (Vascuspec)Device
Also called Low intensity shock wave Therapy, Extracorporeal Shockwave Therapy
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.
Low intensity shock wave therapyDevice
Also called Low Intensity Extra Corporal Shock Wave Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Sham comparator | We use the same probe that induces the same sensation on the penis and the same noise yet no energy Receives: Device: Extracorporeal Shockwave Therapy Generator (Vascuspec) |
| Shock wave therapy | Active comparator | 12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment Receives: Device: Low intensity shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-ED Domain
A change of 5 points or more will indicate success
Measured: 17 weeks
Secondary outcomes (1)
rigidity score
a scale of 3 and above indicates success
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionJan 2012 (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
- Single group
- 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
- Investigators
- Yoram Vardi, prof, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262157
- Sponsor's protocol ID
- 507-10 RMB
- Acronym
- LI-ESWT
- Status last verified
- May 2010
- First submitted
- 11 Jul 2010
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
- ClinicalTrials.gov ID
- NCT01262157
- Acronym / sponsor ID
- LI-ESWT / 507-10 RMB
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.
- 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
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 17 Dec 2010 (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 that do not respond to oral therapy (PDE-5 inhibitors).
Detailed description
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Sham comparator | Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)We use the same probe that induces the same sensation on the penis and the same noise yet no energy |
| Shock wave therapy | Active comparator | Device: Low intensity shock wave therapy12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ED of more than 6 months
- Rigidity score < 3 during PDE5i therapy
- SHIM <21 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
Key exclusion criteria (5 listed)
- Prior prostatectomy surgery
- 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 |
|---|---|---|
| Extracorporeal Shockwave Therapy Generator (Vascuspec)Also: Low intensity shock wave Therapy, Extracorporeal Shockwave TherapyGel 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 | placebo |
| Low intensity shock wave therapyAlso: Low Intensity Extra Corporal Shock Wave TherapyGel 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 | Shock wave therapy |
Primary outcome
IIEF-ED Domain
Time frame: 17 weeks
A change of 5 points or more will indicate success
1 secondary outcome
rigidity score
Time frame: 17 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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, 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 (Vascuspec) and Low intensity shock wave therapy 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 5 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 19 May 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. 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?
Contact Yoram Vardi, Prof (++97248542819, 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?
IIEF-ED Domain (time frame: 17 weeks). 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 19 May 2011.