Erectile Dysfunction Clinical Trial
Official title:
Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) in Patients With Vasculogenic Erectile Dysfunction (ED): Evaluation of the Efficacy of Re-treatment.
The present study evaluates the efficacy and safety of repetitive treatments of Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is, and completed 6 or 12 sessions of LI-ESWT with Aries device during the last 6 month.
This is an extension, 2 parallel arms, clinical trial of a previous study in which patients
were PDE5I users/responders and were randomized to receive either one or two shockwave
treatment sessions per week for a total of 6 weeks, without treatment interval. After
completing the 6-month follow up of the first trial , ED patients will be screened, in order
to identify if the IIEF ED domain is still abnormal (<26). Afterwards, the 2 groups of the
first study will follow the 2 different treatment protocols (once vs twice per week). All
patients will receive 6 treatment sessions with Aries, with the same energy level. First
treatment session will take place between days 0-28 from the day of the 6-month follow up.
All patients will agree and sign a new Informed Consent Form. Therefore, patients who took 6
sessions once a week (Group A in the previous trial) will be switched to take 6 sessions
twice a week in 3 weeks, and those already treated with 12 sessions twice a week (Group B in
the previous trial) will be treated with 6 sessions once a week.
Study visits and duration
Baseline - Visit: the basic work-up will take place, including medical and sexual history, as
well as lab tests, if indicated by medical history. The IIEF-ED domain will be measured, as
well as the Sexual Encounter Profile (SEP) for the last 4-week period with at least 4
attempts for intercourse (without PDE5i use). The study criteria will be checked and if
patients are eligible (IIEF-ED domain <26), they will receive their first repetitive
treatment, either on the same day as the 6-month follow up of the previous study or within
maximum 4 weeks.
Treatment Visits: In all treatment visits, patients will receive active LI-ESWT treatment,
according to the study protocol. Group A will receive treatment twice per week for three
weeks and Group B will receive treatment once per week for six weeks. Interval between 2
treatments will be 7+2days for Group B and 3+1 day for Group A. Adverse events and changes in
concomitant medication will be recorded. PDE5i intake is prohibited throughout the treatment
period.At visit 6 penile ultrasonography will be conducted in order to check for potential
adverse events related to the treatment.
Follow-up visit 1 - 3 (4, 12 and 24 weeks post treatment): the SEP diaries will be returned
and the IIEF-ED domain will be completed for the 4 weeks prior to the aforementioned
timepoints, during which no PDE5i intake is allowed. The document of the visit (protocol
compliance, adverse events) will be completed. At week 12, triplex ultrasonography will be
performed by the standard protocol.
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