Clinical Trial: Effect of Repeating Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) in Patients With Vasculogenic Erectile Dysfunction (ED): Evaluation of the Efficacy of Re-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 Summary:

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
Sponsor: Institute for the Study of Urological Diseases, Greece

Current Primary Outcome: The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF [ Time Frame: at 6 month follow up visit. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in the EF domain score of the IIEF [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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

Original Secondary Outcome: Same as current

Information By: Institute for the Study of Urological Diseases, Greece

Dates:
Date Received: March 20, 2017
Date Started:
Date Completion: April 2017
Last Updated: March 20, 2017
Last Verified: March 2017