Clinical Trial: 6 vs 12 Sessions in Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED): Comparison of 6 Sessions Once a Week vs 12 Sessions Twice Per Week

Brief Summary: The present study aims to identify and compare the efficacy and safety of two different session frequency protocols (once vs twice per week) 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

Detailed Summary:

This is a randomized, 2 parallel arms, clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomized 42 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec). Then the 42 pts will be randomized to receive either one or two shockwave treatment sessions per week, without treatment interval. Every week all subjects may have at least one attempt for intercourse. All patients will complete 6 weeks of treatment.

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. all patients will complete the IIEF-ED domain and will be randomized (1:1) to one of the two parallel study groups, using an online program. Groups A will receive treatment once per week for 6 weeks (6 sessions totally), and Groups B will receive treatment two times per week for 6 weeks (12 sessions totally). PDE5i use is prohibited throughout the study.

Treatment Visits: Patients will receive LI-ESWT , according to the study protocol.Interval between 2 treatments will be 7+2days for Group A and 3+1 day for Group B.At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.

Follow-
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: 30 weeks ]
  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:
Last Updated: March 20, 2017
Last Verified: March 2017