Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol

NCT03089294 | Completed

• 1 other identifier: 13771/2016
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Low intensity extracorporeal shock wave treatment

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 6 month follow up visit

Secondary Outcomes (4)

• Change in the EF domain score of the IIEF

  baseline, 6 month follow up visit and 12 month follow up visit

• Change in Sexual Encounter Profile Question 3 (SEP3) score

  baseline, 6 month follow up visit and 12 month follow up visit

• Change in mean peak systolic velocity (PSV)

  baseline and 3 month follow up visit

• Number of patients with treatment related adverse events

  54 weeks (Group A and Group C), 52 weeks (Group B and Group D)

Study Arms (4)

Group A

ACTIVE COMPARATOR

Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 4 (12 sessions totally)

Device: Aries ED device

Group B

ACTIVE COMPARATOR

Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 4 (12 sessions totally)

Device: Aries ED device

Group C

ACTIVE COMPARATOR

Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 7 (12 sessions totally)

Device: Aries ED device

Group D

ACTIVE COMPARATOR

Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 7 (12 sessions totally)

Device: Aries ED device

Interventions

Aries ED device 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)

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent to participate
• Age \>18
• Presence of vasculogenic erectile dysfunction for at least 6 months
• Positive response to PDE5i
• IIEF-ED score \> 6 and IIEF score \< 26 after wash out of PDE5i
• Abnormal penile triplex-based hemodynamic parameters (peak flow velocity \<35cm/sec)
• Stable heterosexual relationship for more than 3 months
• Sexually active and agree to suspend all ED therapy for the duration of study

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (4)

• 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.

  PMID: 27986492 BACKGROUND

• 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.

  PMID: 27321373 BACKGROUND

• 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.

  PMID: 21855209 BACKGROUND

• 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.

  PMID: 27784587 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Dimitrios Hatzichristou, Prof.

  Institute for the Study of Urological Diseases (ISUD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: May 30, 2016
• Primary Completion: June 6, 2018
• Study Completion: December 10, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)