NCT03089307

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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-up visits 1 - 3 (4, 12 and 24 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 and 24 there is a + 2 weeks visit window.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Dornier Aries- 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).

Timeline

• Start date: 2015-08-18
• Primary completion: 2016-09-13
• Completion: 2016-09-13
• First posted: 2017-03-24
• Last updated: 2017-11-14

Locations

1 site across 1 country: Greece