Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT03089294
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol
Sponsor:
Institute for the Study of Urological Diseases, Greece
Organization:
Study Overview
Official Title:
Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: