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

Primary Purpose

Erectile Dysfunction

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dornier Aries 2

Placebo / Sham

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, shockwave, Dornier

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Patients with generalized polyneuropathy irrespective of cause.
Refusal to suspend ED therapy for duration of study.
Men deemed not healthy enough to participate in sexual activity.
IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
Average EHS ≤ 2 at baseline assessment following "washout".
Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
Known allergy to ultrasound gel.

Sites / Locations

San Diego Sexual Medicine
Adult Pediatric Urology & Urogynecology
Brooklyn Urology Research Group
Manhattan Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo / Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03039218

First Posted

January 26, 2017

Last Updated

August 15, 2018

Sponsor

Dornier MedTech Systems

1. Study Identification

Unique Protocol Identification Number

NCT03039218

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Open-Label Extension Clinical Trial of the Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Commercial decision

Study Start Date

February 7, 2017 (Actual)

Primary Completion Date

March 29, 2018 (Actual)

Study Completion Date

March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dornier MedTech Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with an open-label extension. The study will include 4 sites and multiple investigators. A total of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors will be enrolled. The trial comprises two arms to achieve equal characteristics, where patients are randomly assigned to active treatment or sham treatment. All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2. Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and perfusion improvements to occur. The subjects' duration of participation will be a total of 34 weeks Subjects will also be asked to maintain their current level of sexual activity while participating in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

erectile dysfunction, shockwave, Dornier

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantInvestigator

Masking Description

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

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo / Sham

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Dornier Aries 2

Intervention Description

Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

Intervention Type

Device

Intervention Name(s)

Placebo / Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

International Inventory of Erectile Function ("IIEF")

Description

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

Time Frame

primary outcome at 3 month follow-up visit

Other Pre-specified Outcome Measures:

Title

Erectile Hardness Score

Description

tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.

Time Frame

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

Title

Global Assessment Questionnaire ("GAQ").

Description

2 question questionnaire that assesses improvement in symptoms following treatment

Time Frame

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

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

This study is for males with erectile dysfunction

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Patients with generalized polyneuropathy irrespective of cause. Refusal to suspend ED therapy for duration of study. Men deemed not healthy enough to participate in sexual activity. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period. Average EHS ≤ 2 at baseline assessment following "washout". Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits. Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study. Known allergy to ultrasound gel.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irwin Goldstein

Organizational Affiliation

San Diego Sexual Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego Sexual Medicine

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Adult Pediatric Urology & Urogynecology

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Brooklyn Urology Research Group

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Manhattan Medical Research

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual patient data will not be shared with other researchers.

Citations:

PubMed Identifier

27986492

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.

Results Reference

result

PubMed Identifier

27521134

Citation

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.

Results Reference

result

PubMed Identifier

27447990

Citation

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.

Results Reference

result

PubMed Identifier

27321373

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.

Results Reference

result

PubMed Identifier

26694904

Citation

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.

Results Reference

result

Learn more about this trial

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

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