Erectile DysfunctionNCT03089294
Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol
A study testing Aries ED device in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
Trial summary
The present study aims to identify the efficacy saturation effect of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Aries ED device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGreece
- Study dates
- 30 May 2016to 10 Dec 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate
- Age >18
- Presence of vasculogenic erectile dysfunction for at least 6 months
- Positive response to PDE5i
- IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
- Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
- Stable heterosexual relationship for more than 3 months
- Sexually active and agree to suspend all ED therapy for the duration of study
Who cannot join
- Any cause of ED other than vascular related
- Previous radiation therapy to pelvis
- History of radical prostatectomy
- Clinically significant chronic haematological disease
- Cardiovascular conditions that prevent sexual activity
- Peyronie's Disease or penile curvature
Show all 14Show fewer
- History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
- Anti-androgens oral or injectables androgens
- Untreated Hypogonadism as demonstrated by abnormal testosterone levels
- Malignancy within the past 5 years
- Any unstable medical, psychiatric condition or spinal cord injury
- Anatomical or neurological abnormalities in the treatment area
- Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
- Known allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
The present study aims to identify the efficacy saturation effect of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and safety of 4 different session frequency protocols will be compared.
Read the detailed description
This is a randomized, 4 parallel arms, clinical trial with an 18-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 96 men with vasculogenic ED, an International Index of Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec) in the last 6 months. Additionally, they will be asked to complete the SEP diaries. Patients will be randomized to receive shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks) or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.
Study visits and duration
Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as well as necessary lab tests, if needed. One month wash-out period will follow. During this period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least 2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography, unless they have already done so in the last 6 months.Also penile dimensions in both flaccid and erect state will be measured.
Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be randomized to one of the four parallel study groups, using an online program. Groups A and C will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use is prohibited throughout the study.
Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1 days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week). At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.
Follow-up visits 1 - 3 (4, 12 ,24 and 48 weeks post treatment): Patients will complete the IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week 12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit window, whereas for weeks 12, 24 and 48 there is a + 2 weeks visit window.
- Conditions
- Erectile Dysfunction
- Being tested
- Aries ED device
- Keywords
- Erectile Dysfunction, Low intensity extracorporeal shock wave treatment
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aries ED deviceDevice
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 4 (12 sessions totally) Receives: Device: Aries ED device |
| Group B | Active comparator | Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 4 (12 sessions totally) Receives: Device: Aries ED device |
| Group C | Active comparator | Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 7 (12 sessions totally) Receives: Device: Aries ED device |
| Group D | Active comparator | Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 7 (12 sessions totally) Receives: Device: Aries ED device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
MCID is defined according to baseline ED severity as:
- Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline.
- Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline
- Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline
Measured: baseline and 6 month follow up visit
Secondary outcomes (4)
Change in the EF domain score of the IIEF
EF domain of the IIEF questionnaire will be completed
Measured: baseline, 6 month follow up visit and 12 month follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
Measured: baseline, 6 month follow up visit and 12 month follow up visit
Change in mean peak systolic velocity (PSV)
Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator.
Measured: baseline and 3 month follow up visit
Number of patients with treatment related adverse events
Potential treatment related adverse events after the first LI-ESWT session and during the 12 month follow up period will be reported
Measured: 54 weeks (Group A and Group C), 52 weeks (Group B and Group D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start30 May 2016
- Primary completion6 Jun 2018
- Study completion10 Dec 2018
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 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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for the Study of Urological Diseases, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece
- Investigators
- Dimitrios Hatzichristou, Prof., Principal investigator, Institute for the Study of Urological Diseases (ISUD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089294
- Sponsor's protocol ID
- 13771/2016
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
PubMed 27986492Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
PubMed 27321373Rosen 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 21855209Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
PubMed 27784587
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
- ClinicalTrials.gov ID
- NCT03089294
- Acronym / sponsor ID
- 13771/2016
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Low intensity extracorporeal shock wave treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institute for the Study of Urological Diseases, GreeceUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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.
The present study aims to identify the efficacy saturation effect of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and safety of 4 different session frequency protocols will be compared.
Detailed description
This is a randomized, 4 parallel arms, clinical trial with an 18-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 96 men with vasculogenic ED, an International Index of Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec) in the last 6 months. Additionally, they will be asked to complete the SEP diaries. Patients will be randomized to receive shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks) or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.
Study visits and duration
Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as well as necessary lab tests, if needed. One month wash-out period will follow. During this period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least 2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography, unless they have already done so in the last 6 months.Also penile dimensions in both flaccid and erect state will be measured.
Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be randomized to one of the four parallel study groups, using an online program. Groups A and C will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use is prohibited throughout the study.
Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1 days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week). At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.
Follow-up visits 1 - 3 (4, 12 ,24 and 48 weeks post treatment): Patients will complete the IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week 12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit window, whereas for weeks 12, 24 and 48 there is a + 2 weeks visit window.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Aries ED devicePatients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 4 (12 sessions totally) |
| Group B | Active comparator | Device: Aries ED devicePatients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 4 (12 sessions totally) |
| Group C | Active comparator | Device: Aries ED devicePatients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 7 (12 sessions totally) |
| Group D | Active comparator | Device: Aries ED devicePatients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 7 (12 sessions totally) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Consent to participate
- Age >18
- Presence of vasculogenic erectile dysfunction for at least 6 months
- Positive response to PDE5i
- IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
Key exclusion criteria (14 listed)
- Any cause of ED other than vascular related
- Previous radiation therapy to pelvis
- History of radical prostatectomy
- Clinically significant chronic haematological disease
- 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 |
|---|---|---|
| Aries ED deviceThe Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites) | Device | Group A, Group B, Group C, Group D |
Primary outcome
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
Time frame: baseline and 6 month follow up visit
MCID is defined according to baseline ED severity as: * Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline. * Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline * Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline
4 secondary outcomes
Change in the EF domain score of the IIEF
Time frame: baseline, 6 month follow up visit and 12 month follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
Time frame: baseline, 6 month follow up visit and 12 month follow up visit
Change in mean peak systolic velocity (PSV)
Time frame: baseline and 3 month follow up visit
Number of patients with treatment related adverse events
Time frame: 54 weeks (Group A and Group C), 52 weeks (Group B and Group D)
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 26 Mar 2019.
- Background: PubMed 27986492Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
- Background: PubMed 27321373Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
- 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.
- Background: PubMed 27784587Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
- Individual participant dataSharing planned: No
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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.
Dimitrios Hatzichristou, Prof. principal investigator
Institute for the Study of Urological Diseases (ISUD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aries ED device in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
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 8 inclusion and 14 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 26 Mar 2019. 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 Greece. 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. 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?
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF (time frame: baseline and 6 month follow up visit). 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 NCT03089294, 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 26 Mar 2019.