Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03089294
Brief Summary:
The present study aims to identify the efficacy saturation effect 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. The efficacy and safety of 4 different session frequency protocols will be compared.
Detailed Description:
This is a randomized, 4 parallel arms, clinical trial with an 18-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 96 men with vasculogenic ED, an International Index of Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity \<35cm/sec) in the last 6 months. Additionally, they will be asked to complete the SEP diaries. Patients will be randomized to receive shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks) or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.
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.Also penile dimensions in both flaccid and erect state will be measured.
Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be randomized to one of the four parallel study groups, using an online program. Groups A and C will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use is prohibited throughout the study.
Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1 days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week). 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 ,24 and 48 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, 24 and 48 there is a + 2 weeks visit window.
Study:
NCT03089294
Study Brief:
Protocol Section:
NCT03089294