Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Low intensity extracorporeal shock wave treatment
Brief summary
The present study evaluates the efficacy and safety of repetitive treatments of Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is, and completed 6 or 12 sessions of LI-ESWT with Aries device during the last 6 month.
Detailed description
This is an extension, 2 parallel arms, clinical trial of a previous study in which patients were PDE5I users/responders and were randomized to receive either one or two shockwave treatment sessions per week for a total of 6 weeks, without treatment interval. After completing the 6-month follow up of the first trial , ED patients will be screened, in order to identify if the IIEF ED domain is still abnormal (\<26). Afterwards, the 2 groups of the first study will follow the 2 different treatment protocols (once vs twice per week). All patients will receive 6 treatment sessions with Aries, with the same energy level. First treatment session will take place between days 0-28 from the day of the 6-month follow up. All patients will agree and sign a new Informed Consent Form. Therefore, patients who took 6 sessions once a week (Group A in the previous trial) will be switched to take 6 sessions twice a week in 3 weeks, and those already treated with 12 sessions twice a week (Group B in the previous trial) will be treated with 6 sessions once a week. Study visits and duration Baseline - Visit: the basic work-up will take place, including medical and sexual history, as well as lab tests, if indicated by medical history. The IIEF-ED domain will be measured, as well as the Sexual Encounter Profile (SEP) for the last 4-week period with at least 4 attempts for intercourse (without PDE5i use). The study criteria will be checked and if patients are eligible (IIEF-ED domain \<26), they will receive their first repetitive treatment, either on the same day as the 6-month follow up of the previous study or within maximum 4 weeks. Treatment Visits: In all treatment visits, patients will receive active LI-ESWT treatment, according to the study protocol. Group A will receive treatment twice per week for three weeks and Group B will receive treatment once per week for six weeks. Interval between 2 treatments will be 7+2days for Group B and 3+1 day for Group A. Adverse events and changes in concomitant medication will be recorded. PDE5i intake is prohibited throughout the treatment period.At visit 6 penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment. Follow-up visit 1 - 3 (4, 12 and 24 weeks post treatment): the SEP diaries will be returned and the IIEF-ED domain will be completed for the 4 weeks prior to the aforementioned timepoints, during which no PDE5i intake is allowed. The document of the visit (protocol compliance, adverse events) will be completed. At week 12, triplex ultrasonography will be performed by the standard protocol.
Interventions
DEVICEARIES-ED device
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).
Sponsors
Institute for the Study of Urological Diseases, Greece
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consent to participate 2. Age \>18 3. Presence of vasculogenic erectile dysfunction for at least 6 months 4. Positive response to PDE5i 5. Patients who completed the 6 months follow-up of a previous study including 6 or 12 sessions of LI-ESWT with Aries device and still have an abnormal IIEF ED domain (\< 26) 6. Abnormal penile triplex-based hemodynamic parameters (peak flow velocity \<35cm/sec) 7. Stable heterosexual relationship for more than 3 months 8. Sexually active and agree to suspend all ED therapy for the duration of study
Exclusion criteria
1. Any cause of ED other than vascular related 2. Previous radiation therapy to pelvis 3. History of radical prostatectomy 4. Clinically significant chronic haematological disease 5. Cardiovascular conditions that prevent sexual activity 6. Peyronie's Disease or penile curvature 7. History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month 8. Anti-androgens oral or injectables androgens 9. Untreated Hypogonadism as demonstrated by abnormal testosterone levels 10. Malignancy within the past 5 years 11. Any unstable medical, psychiatric condition or spinal cord injury 12. Anatomical or neurological abnormalities in the treatment area 13. Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories) 14. Known allergy to ultrasound gel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF | at 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the EF domain score of the IIEF | baseline and 6 month follow up visit | EF domain of the IIEF questionnaire will be completed |
| Change in Sexual Encounter Profile Question 3 (SEP3) score | baseline and 6 month follow up visit | The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported |
| Change in mean peak systolic velocity (PSV) | baseline and 3 month follow up visit | Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator. |
| Number of patients with treatment related adverse events | 27 months (Group A) ,30 months (Group B) | Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported |
Countries
Greece
Outcome results
None listed