Vasculogenic Erectile DysfunctionNCT01811797
Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
A study testing Low Intensity Shockwave by Renova 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 comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham 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?
- Low Intensity Shockwave by Renova
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Jun 2014
- 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
- Vascular 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
- Hormonal, neurological or psychological pathology
- Past radical prostatectomy or extensive pelvic surgery
- Recovering from cancer during last 5 years
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Past radiotherapy treatment of the pelvic region
- International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
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 Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.
- Conditions
- Vasculogenic Erectile Dysfunction
- Being tested
- Low Intensity Shockwave by Renova, Sham treatment
- Keywords
- Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Shockwave by RenovaDevice
Sham treatmentDevice
Sham treatment that looks, sounds and feels like the real LISW treatment.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Shockwave treatment | Experimental | 4 weekly sessions of Low Intensity Shockwave treatment. Receives: Device: Low Intensity Shockwave by Renova |
| 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 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Secondary outcomes (5)
Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
Measured: 0 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 posted15 Mar 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Initia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811797
- Sponsor's protocol ID
- RENO-03-ICH
- Status last verified
- May 2015
- First submitted
- 13 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 20451317Vardi Y, Appel B, Kilchevsky A, Gruenwald I. 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. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
PubMed 22425129Rosen 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 Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova
- ClinicalTrials.gov ID
- NCT01811797
- Acronym / sponsor ID
- RENO-03-ICH
- Conditions
- Vasculogenic Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- InitiaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 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 comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Shockwave treatment | Experimental | Device: Low Intensity Shockwave by Renova4 weekly sessions of Low Intensity Shockwave treatment. |
| 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
- Vascular 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 (8 listed)
- Hormonal, neurological or psychological pathology
- Past radical prostatectomy or extensive pelvic surgery
- Recovering from cancer during last 5 years
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
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 |
|---|---|---|
| Low Intensity Shockwave by Renova | Device | Low Intensity Shockwave treatment |
| Sham treatmentSham treatment that looks, sounds and feels like the real LISW treatment. | Device | Control group |
Primary outcome
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
5 secondary outcomes
Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
Time frame: 0 and 6 months post treatment
Results and safety
The study was stopped early. Results are not available in the source record.
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 22425129Vardi Y, Appel B, Kilchevsky A, Gruenwald I. 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. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Shockwave by Renova 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 8 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: stopped early, 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 was stopped early. Results are not available in the source record.
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 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 NCT01811797, 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.