Clinical trial NCT03089372: Effect of Repeating Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)
Official title: Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) in Patients With Vasculogenic Erectile Dysfunction (ED): Evaluation of the Efficacy of Re-treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Low intensity extracorporeal shock wave treatment
Lead sponsor: Institute for the Study of Urological Diseases, Greece
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Consent to participate
2. Age \>18
3. Presence of vasculogenic erectile dysfunction for at least 6 months
4. Positive response to PDE5i
5. Patients who completed the 6 months follow-up of a previous study including 6 or 12 sessions of LI-ESWT with Aries device and still have an abnormal IIEF ED domain (\< 26)
6. Abnormal penile triplex-based hemodynamic parameters (peak flow velocity \<35cm/sec)
7. Stable heterosexual relationship for more than 3 months
8. Sexually active and agree to suspend all ED therapy for the duration of study

Exclusion Criteria:

1. Any cause of ED other than vascular related
2. Previous radiation therapy to pelvis
3. History of radical prostatectomy
4. Clinically significant chronic haematological disease
5. Cardiovascular conditions that prevent sexual activity
6. Peyronie's Disease or penile curvature
7. History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
8. Anti-androgens oral or injectables androgens
9. Untreated Hypogonadism as demonstrated by abnormal testosterone levels
10. Malignancy within the past 5 years
11. Any unstable medical, psychiatric condition or spinal cord injury
12. Anatomical or neurological abnormalities in the treatment area
13. Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
14. Known allergy to ultrasound gel

Primary outcomes:
measure: The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
timeFrame: at 6 month follow up visit.
Secondary outcomes:
measure: Change in the EF domain score of the IIEF
timeFrame: baseline and 6 month follow up visit
measure: Change in Sexual Encounter Profile Question 3 (SEP3) score
timeFrame: baseline and 6 month follow up visit
measure: Change in mean peak systolic velocity (PSV)
timeFrame: baseline and 3 month follow up visit
measure: Number of patients with treatment related adverse events
timeFrame: 27 months (Group A) ,30 months (Group B)
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G.Gennimatas Hospital
Study officials:
affiliation: Institute for the Study of Urological Diseases (ISUD)
name: Dimitrios Hatzichristou, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
citation: Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
citation: Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
citation: Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
citation: Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.