Erectile Dysfunction Clinical Trial
Official title:
Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
Verified date | March 2019 |
Source | Institute for the Study of Urological Diseases, Greece |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | December 10, 2018 |
Est. primary completion date | June 6, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Greece | G.Gennimatas Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Institute for the Study of Urological Diseases, Greece |
Greece,
Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13. Review. — View Citation
Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18. Review. — View Citation
Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16. Review. — View Citation
Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
baseline and 6 month follow up visit | |
Secondary | Change in the EF domain score of the IIEF | EF domain of the IIEF questionnaire will be completed | baseline, 6 month follow up visit and 12 month follow up visit | |
Secondary | 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, 6 month follow up visit and 12 month follow up visit | |
Secondary | 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 | |
Secondary | Number of patients with treatment related adverse events | Potential treatment related adverse events after the first LI-ESWT session and during the 12 month follow up period will be reported | 54 weeks (Group A and Group C), 52 weeks (Group B and Group D) |
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