Erectile Dysfunction Clinical Trial
Official title:
Low-intensity Shockwaves Therapy Co-administered With Tadalafil 5mg for the Treatment of Severe, Vasculogenic Erectile Dysfunction:Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial
This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
| Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
| Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
| Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
| Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
| Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
| Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
| Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
| Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
| Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
| Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
| Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
| Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
| Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 | |
| Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 | |
| Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 |