Effect of Repeating Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: ARIES-ED device

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54621
    • G.Gennimatas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients will receive two sessions of LI-ESWT per week for a 3 week period (6 sessions totally)	Device: ARIES-ED device; The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).
Active Comparator: Group B; Patients will receive one session of LI-ESWT per week for a 6 week period (6 sessions totally)	Device: ARIES-ED device; The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF	MCID is defined according to baseline ED severity as: Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline.; Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline; Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline	at 6 month follow up visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the EF domain score of the IIEF	EF domain of the IIEF questionnaire will be completed	baseline and 6 month follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score	The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported	baseline and 6 month follow up visit
Change in mean peak systolic velocity (PSV)	Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator.	baseline and 3 month follow up visit
Number of patients with treatment related adverse events	Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported	27 months (Group A) ,30 months (Group B)

Collaborators and Investigators

• Sponsor: Institute for the Study of Urological Diseases, Greece

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 12, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Low intensity extracorporeal shock wave treatment
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: 4240/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No