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

NCT03642366 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-05-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Institute for the Study of Urological Diseases, Greece

    lead OTHER

Principal Investigators

  • Dimitrios Hatzichristou, Prof. · Institute for the Study of Urological Diseases, Thessaloniki, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642366 on ClinicalTrials.gov