NCT03089372

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (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 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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	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: 2016-05-09
• Primary completion: 2017-04-04
• Completion: 2017-04-04
• First posted: 2017-03-24
• Last updated: 2017-11-14

Locations

1 site across 1 country: Greece