Vasculogenic Erectile DysfunctionNCT01814852
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction
A study testing Shockwave system in people with Vasculogenic Erectile Dysfunction, run by Initia at 1 site in Israel.
Trial summary
This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Vasculogenic Erectile Dysfunction
- What is being tested?
- Shockwave system
- 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
- Dec 2012to Feb 2015
- Phase
- Interventional
- 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
- Good general health
- Vasculogenic ED for at least 6 months
- International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
- Positive response to PDE5-I (able to penetrate on demand, Responders)
- Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
- Stable heterosexual relationship for more than 3 months
Who cannot join
- Psychogenic ED
- Neurological pathology
- Hormonal pathology
- Past radical prostatectomy
- Recovering from cancer during last 5 years
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
Show all 9Show fewer
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Radiotherapy in pelvic region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Read the detailed description
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.
- Conditions
- Vasculogenic Erectile Dysfunction
- Being tested
- Shockwave system, Sham treatment
- Keywords
- Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave systemDevice
Also called Renova
Sham treatmentDevice
Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.
| Study group | Role | What they receive |
|---|---|---|
| Shockwaves | Experimental | 4 weekly sessions of low-intensity shockwave therapy Receives: Device: Shockwave system |
| Control Group | Sham comparator | Not described Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Secondary outcomes (2)
Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vasculogenic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Initia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uri Gur, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814852
- Sponsor's protocol ID
- RENO-006B-MR
- Status last verified
- May 2015
- First submitted
- 18 Mar 2013
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
PubMed 20451317Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
PubMed 22999553Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
PubMed 12152111Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
PubMed 21855209
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01814852
- Acronym / sponsor ID
- RENO-006B-MR
- Conditions
- Vasculogenic Erectile Dysfunction
- Keywords
- Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- InitiaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Mar 2013 (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 is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Detailed description
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwaves | Experimental | Device: Shockwave system4 weekly sessions of low-intensity shockwave therapy |
| Control Group | Sham comparator | Device: Sham treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Good general health
- Vasculogenic ED for at least 6 months
- International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
- Positive response to PDE5-I (able to penetrate on demand, Responders)
- Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
Key exclusion criteria (9 listed)
- Psychogenic ED
- Neurological pathology
- Hormonal pathology
- Past radical prostatectomy
- Recovering from cancer during last 5 years
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 |
|---|---|---|
| Shockwave systemAlso: Renova | Device | Shockwaves |
| Sham treatmentSham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova. | Device | Control Group |
Primary outcome
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
2 secondary outcomes
Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
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 12 May 2015.
- Background: PubMed 20451317Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
- Background: PubMed 22999553Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
- Background: PubMed 12152111Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
- Background: PubMed 21855209Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
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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.
Uri Gur, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave system in people with Vasculogenic Erectile Dysfunction, run by Initia 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 6 inclusion and 9 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 12 May 2015. 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.
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?
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment (time frame: 1, 3 and 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814852, which also lists 4 linked publications.
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 12 May 2015.