Erectile Dysfunction Clinical Trial
Official title:
Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
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.
This is a randomized, 4 parallel arms, clinical trial with an 18-month recruitment period.
All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will
be screened, in order to randomize 96 men with vasculogenic ED, an International Index of
Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based
hemodynamic parameters (peak flow velocity <35cm/sec) in the last 6 months. Additionally,
they will be asked to complete the SEP diaries. Patients will be randomized to receive
shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks)
or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.
Study visits and duration
Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as
well as necessary lab tests, if needed. One month wash-out period will follow. During this
period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least
2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography,
unless they have already done so in the last 6 months.Also penile dimensions in both flaccid
and erect state will be measured.
Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be
randomized to one of the four parallel study groups, using an online program. Groups A and C
will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D
will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use
is prohibited throughout the study.
Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will
receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1
days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week).
At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential
adverse events related to the treatment.
Follow-up visits 1 - 3 (4, 12 ,24 and 48 weeks post treatment): Patients will complete the
IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to
every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week
12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit
window, whereas for weeks 12, 24 and 48 there is a + 2 weeks visit window.
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