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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Dornier Aries- ED device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to participate Age >18 Presence of vasculogenic erectile dysfunction for at least 6 months Positive response to PDE5i IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec) Stable heterosexual relationship for more than 3 months Sexually active and agree to suspend all ED therapy for the duration of study Exclusion Criteria: Any cause of ED other than vascular related Previous radiation therapy to pelvis History of radical prostatectomy Clinically significant chronic haematological disease Cardiovascular conditions that prevent sexual activity Peyronie's Disease or penile curvature History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month Anti-androgens oral or injectables androgens Untreated Hypogonadism as demonstrated by abnormal testosterone levels Malignancy within the past 5 years Any unstable medical, psychiatric condition or spinal cord injury Anatomical or neurological abnormalities in the treatment area Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories) Known allergy to ultrasound gel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients (n=44) will be randomised into 2 groups to receive low intensity extracorporeal shock wave treatment for a 6 weeks period utilising the Dornier Aries ED device.Group A (n=21) will receive 6 sessions (one session per week) and group B (n=21) will receive 12 sessions (2 sessions per week).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally). | Device: Dornier Aries- ED device<br>* 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).<br>|
| Active Comparator: Group B<br>Patients will receive two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally). | Device: Dornier Aries- ED device<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF | MCID is defined according to baseline ED severity as: Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline. Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline | at 6 month follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the EF domain score of the IIEF | EF domain of the IIEF questionnaire will be completed | baseline and 6 month follow up visit. | 
| Change in Sexual Encounter Profile Question 3 (SEP3) score | The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported | baseline and 6 month follow up visit. | 
| Change in mean peak systolic velocity (PSV) | Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator. | baseline and 3 month follow up visit | 
| Number of patients with treatment related adverse events | Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported | 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Low intensity extracorporeal shock wave treatment