Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)

NCT03039218 | Terminated DMC FDA Device

• 1 other identifier: G140216 S004
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; shockwave; Dornier

Outcome Measures

Primary Outcomes (1)

• International Inventory of Erectile Function ("IIEF")

  validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials

  primary outcome at 3 month follow-up visit

Other Outcomes (2)

• Erectile Hardness Score

  Proportion of patients with an EHS=4 at the 3 month follow-up visit

• Global Assessment Questionnaire ("GAQ").

  The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects assigned to this group will receive Active treatments using the Dornier Aries 2.

Device: Dornier Aries 2

Placebo / Sham

PLACEBO COMPARATOR

Subjects assigned to this group will receive placebo / sham (no active treatment).

Device: Placebo / Sham

Interventions

Dornier Aries 2 DEVICE

Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

Active

Placebo / Sham DEVICE

Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

Placebo / Sham

Eligibility Criteria

• Age: 22 Years - 70 Years
• Gender Eligibility Details: This study is for males with erectile dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent to participate.
• Age 22-70 years.
• Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
• Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
• IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
• IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.
• In a stable heterosexual relationship of more than three months duration.
• Sexually active and agree to suspend all ED therapy for duration of study.
• Agree to maintain their normal sexual habits.

You may not qualify if:

• Radical prostatectomy.
• Previous radiation therapy to pelvis.
• Previous stem cell or platelet rich plasma therapy.
• Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
• Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
• Hormone usage, other than testosterone, clomiphene or thyroid medication.
• Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
• Psychogenic ED.
• Peyronie's Disease or penile curvature that negatively influences sexual activity.
• Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
• Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood tests.
• Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
• Patients with cardiac or non-cardiac electrical devices implanted.
• Anatomical or neurological abnormalities in the treatment area.
• Diabetes Mellitus with severe polyneuropathy.

Sponsors & Collaborators

• Dornier MedTech Systems: lead

Study Sites (4)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Adult Pediatric Urology & Urogynecology

Omaha, Nebraska, 68114, United States

Location

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Related Publications (5)

• 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 RESULT

• 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 RESULT

• Zou ZJ, Liu ZH, Tang LY, Lu YP. Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors? World J Urol. 2017 Jan;35(1):167-171. doi: 10.1007/s00345-016-1899-y. Epub 2016 Jul 22. No abstract available.

  PMID: 27447990 RESULT

• 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 RESULT

• Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016 May;195(5):1550-1555. doi: 10.1016/j.juro.2015.12.049. Epub 2015 Dec 13.

  PMID: 26694904 RESULT

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

• Irwin Goldstein

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study subjects will be randomized in a 2:1 ratio to either active treatment or the control. The investigator and his staff do not know which applicator is the sham/placebo control and which are the active applicators. For the active treatment, a regular EMSE shockwave applicator will be used. The treatment group is further split into two equal groups, with both groups receiving the identical active treatment. In order to preserve the blinding of the investigator, the treatment devices are provided with two applicators (one for each of the active treatment groups), which while identical in function, differ slightly in appearance. For the sham treatment, a placebo applicator, including an absorber without emitting shockwaves, will be used. However, all three applicators (two to use with the active device and one with the sham) are going to produce exactly the typical shock wave sound with equivalent noise to reduce or eliminate bias from the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 100 subjects will be randomized to either the Active or Sham/Placebo group. Following completion of the 3 month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/Sham treatment will be offered treatment using the Active device applicator.

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 1, 2017
• Study Start: February 7, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)