NCT03642366

Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
OTHER	Dornier Aries2 LiST Device + 5mg Tadalafil (1)	Patients will 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. 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.
OTHER	Dornier Aries2 LiST Device + 5mg Tadalafil (2)	Patients will 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. 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.
OTHER	Sham LiST Device + 5mg Tadalafil	Patients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. 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.

Timeline

• Start date: 2018-08-27
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2018-08-22
• Last updated: 2022-05-05

Locations

1 site across 1 country: Greece