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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03089294 |
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Date of registration:
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20/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol
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Scientific title:
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Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol |
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Date of first enrolment:
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May 30, 2016 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03089294 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Dimitrios Hatzichristou, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for the Study of Urological Diseases (ISUD) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Consent to participate
2. Age >18
3. Presence of vasculogenic erectile dysfunction for at least 6 months
4. Positive response to PDE5i
5. IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
6. Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
7. Stable heterosexual relationship for more than 3 months
8. Sexually active and agree to suspend all ED therapy for the duration of study
Exclusion Criteria:
1. Any cause of ED other than vascular related
2. Previous radiation therapy to pelvis
3. History of radical prostatectomy
4. Clinically significant chronic haematological disease
5. Cardiovascular conditions that prevent sexual activity
6. Peyronie's Disease or penile curvature
7. History of heart attack, stroke or any life- threatening arrhythmia within the prior 6
month
8. Anti-androgens oral or injectables androgens
9. Untreated Hypogonadism as demonstrated by abnormal testosterone levels
10. Malignancy within the past 5 years
11. Any unstable medical, psychiatric condition or spinal cord injury
12. Anatomical or neurological abnormalities in the treatment area
13. Use of any treatment for ED within 7 days of screening ( oral medications, vacuum
devices, constrictive devices, injections or urethral suppositories)
14. Known allergy to ultrasound gel
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
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Intervention(s)
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Device: Aries ED device
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Primary Outcome(s)
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The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
[Time Frame: baseline and 6 month follow up visit]
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Secondary Outcome(s)
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Change in mean peak systolic velocity (PSV)
[Time Frame: baseline and 3 month follow up visit]
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Number of patients with treatment related adverse events
[Time Frame: 54 weeks (Group A and Group C), 52 weeks (Group B and Group D)]
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Change in Sexual Encounter Profile Question 3 (SEP3) score
[Time Frame: baseline, 6 month follow up visit and 12 month follow up visit]
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Change in the EF domain score of the IIEF
[Time Frame: baseline, 6 month follow up visit and 12 month follow up visit]
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Secondary ID(s)
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13771/2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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