Erectile DysfunctionPhase 3LI-ESWTNCT01274923
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders
A Phase 3 study testing "MEDISPEC" treatment probe in people with Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner. 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?
- "MEDISPEC" treatment probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Oct 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED of more than 6 months
- Rigidity score ≥ 3 under PDE5i therapy
- SHIM ≤21 under 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 Health Care Campus
Haifa, Haifa District, 31096
Ilan Gruenwald, MD, 00972544474341, i_gruuenwald@rambam.health.gov.il
Yoram Vardi, Prof.
About this study
Official title: The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
Read the detailed description
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment
- Conditions
- Erectile Dysfunction
- Being tested
- "MEDISPEC" treatment probe
- Keywords
- Erectile dysfunction, Low Intensity Shock Wave
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"MEDISPEC" treatment probeDevice
Also called Omnispec model ED1000
shock wave treatment
| Study group | Role | What they receive |
|---|---|---|
| shock wave treatment | Sham comparator | Not described Receives: Device: "MEDISPEC" treatment probe |
| "MEDISPEC" Sham | Sham comparator | "MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe Receives: Device: "MEDISPEC" treatment probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile function- Erectile Function Domain
An increase in score of 5points and above will be considered success.
Measured: At screening and 17 weeks later at last visit
Secondary outcomes (2)
Rigidity scale
A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success
Measured: At screening and 17 weeks later at last visit
Flow Mediated Dilatation Technique
A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.
Measured: At screening and 17 weeks later at last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionOct 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Medispec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274923
- Sponsor's protocol ID
- 0200-09-rmb europe
- Acronym
- LI-ESWT
- Status last verified
- Jan 2011
- First submitted
- 9 Jan 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
- ClinicalTrials.gov ID
- NCT01274923
- Acronym / sponsor ID
- LI-ESWT / 0200-09-rmb europe
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Low Intensity Shock Wave
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Medispec
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 12 Jan 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.
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
Detailed description
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment
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 |
|---|---|---|
| shock wave treatment | Sham comparator | Device: "MEDISPEC" treatment probe |
| "MEDISPEC" Sham | Sham comparator | Device: "MEDISPEC" treatment probe"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ED of more than 6 months
- Rigidity score ≥ 3 under PDE5i therapy
- SHIM ≤21 under 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 |
|---|---|---|
| "MEDISPEC" treatment probeAlso: Omnispec model ED1000shock wave treatment | Device | "MEDISPEC" Sham, shock wave treatment |
Primary outcome
International Index of Erectile function- Erectile Function Domain
Time frame: At screening and 17 weeks later at last visit
An increase in score of 5points and above will be considered success.
2 secondary outcomes
Rigidity scale
Time frame: At screening and 17 weeks later at last visit
Flow Mediated Dilatation Technique
Time frame: At screening and 17 weeks later at last visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
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 "MEDISPEC" treatment probe 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 5 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 18 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 Ilan Gruenwald, MD (00972544474341, i_gruenwald@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile function- Erectile Function Domain (time frame: At screening and 17 weeks later at last visit). 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 May 2011.