Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-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 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Group | Sham Comparator | The subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) by the sham probe. |
|
| Active Group | Active Comparator | The subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) at energy level 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dornier Aries2 device | Device | The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the 2 groups in 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 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline | at 3 month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the 2 groups in the change of the EF domain score of the IIEF | EF domain of the IIEF questionnaire will be completed | baseline and 3 month follow up visit. |
| Change in Sexual Encounter Profile Question 3 (SEP3) score |
Not provided
Inclusion Criteria:
13. At Visit 2, IIEF Q3 score 2 - 5. 14. At Visit 2, IIEF Q4 score 1 - 3.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitris Hatzichristou, Prof. | G.Gennimatas General Hospital, Thessaloniki,Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G.Gennimatas Hospital | Thessaloniki | 54621 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29396020 | Background | Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1. | |
| 28673433 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dornier Aries2 device (sham probe) | Device | The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe. |
|
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
| 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 3 month follow up period will be reported | 18 weeks |
| Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |