Erectile DysfunctionPhase 3LI-ESWTNCT01272297
The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders
A Phase 3 study testing LI-ESWT in people with Erectile Dysfunction, run by Rambam Health Care Campus.
Trial summary
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy. 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?
- LI-ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2010
- 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
- ED of more than 6 months
- Rigidity score ≤ 2 during PDE5i therapy
- Stable heterosexual relationship for more than 3 months
- Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .
Who cannot join
- Prior surgery or radiotherapy in pelvic region
- Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Cardiovascular conditions that prevent sexual activity
About this study
Official title: The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
Read the detailed description
We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.
- Conditions
- Erectile Dysfunction
- Being tested
- LI-ESWT
- Keywords
- LI-ESWT, Erectile Dysfunction, Non PDE5 inhibitor responders, 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.
LI-ESWTDevice
Also called Omnispec model ED1000
Low intensity shock wave treatment - 12 sessions
| Study group | Role | What they receive |
|---|---|---|
| LI-ESWT | Experimental | Low intensity shock wave treatment- 12 sessions Receives: Device: LI-ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-ED Domain score
Change of 5 points and above in IIEF-ED Domain score
Measured: 17 weeks after first visit
Secondary outcomes (1)
rigidity scale
a change to 3 or 4 points in the rigidty scale
Measured: 17 weeks from visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Medispec
- Responsible party
- Principal investigator, i_gruenwald, Rambam Health Care Campus
- Investigators
- Yoram Vardi, Prof, Principal investigator, Rambam Health Care CampusIlan Gruenwald, MD, Study director, Rambam Health Care CampusBoaz Appel, MD, Study director, Rambam Health Care CampusEzra Gerber, RN, Study director, Rambam Health Care CampusYaron Ofer, MD, Study director, Rambam Health Care CampusOmar Massarwa, RN, Study director, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272297
- Sponsor's protocol ID
- shock wave III
- Acronym
- LI-ESWT
- Status last verified
- Dec 2012
- First submitted
- 14 Dec 2010
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
- ClinicalTrials.gov ID
- NCT01272297
- Acronym / sponsor ID
- LI-ESWT / shock wave III
- Conditions
- Erectile Dysfunction
- Keywords
- LI-ESWT, Erectile Dysfunction, Non PDE5 inhibitor responders, Shock wave
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Medispec
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 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.
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
Detailed description
We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LI-ESWT | Experimental | Device: LI-ESWTLow intensity shock wave treatment- 12 sessions |
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)
- ED of more than 6 months
- Rigidity score ≤ 2 during PDE5i therapy
- Stable heterosexual relationship for more than 3 months
- Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .
Key exclusion criteria (5 listed)
- Prior surgery or radiotherapy in pelvic region
- Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- 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 |
|---|---|---|
| LI-ESWTAlso: Omnispec model ED1000Low intensity shock wave treatment - 12 sessions | Device | LI-ESWT |
Primary outcome
IIEF-ED Domain score
Time frame: 17 weeks after first visit
Change of 5 points and above in IIEF-ED Domain score
1 secondary outcome
rigidity scale
Time frame: 17 weeks from visit 1
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 19 Dec 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
Ilan Gruenwald, MD study director
Rambam Health Care Campus
Boaz Appel, MD study director
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LI-ESWT in people with Erectile Dysfunction, run by Rambam Health Care Campus.
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: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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-ED Domain score (time frame: 17 weeks after first 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 19 Dec 2012.