6 vs 12 Sessions in Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

NCT03089307 | Completed

• 1 other identifier: 1490/15
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to identify and compare the efficacy and safety of two different session frequency protocols (once vs twice per week) 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

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

  at 6 month follow up visit

Secondary Outcomes (4)

• Change in the EF domain score of the IIEF

  baseline and 6 month follow up visit.

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

  baseline and 6 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

  30 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally).

Device: Dornier Aries- ED device

Group B

ACTIVE COMPARATOR

Patients will receive two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally).

Device: Dornier Aries- ED device

Interventions

Dornier 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

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 (5)

• 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

• Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish.

  PMID: 27521134 BACKGROUND

• 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.

  PMID: 20451317 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

• 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

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

Model Details: Eligible patients (n=44) will be randomised into 2 groups to receive low intensity extracorporeal shock wave treatment for a 6 weeks period utilising the Dornier Aries ED device.Group A (n=21) will receive 6 sessions (one session per week) and group B (n=21) will receive 12 sessions (2 sessions per week).

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: August 18, 2015
• Primary Completion: September 13, 2016
• Study Completion: September 13, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)