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

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ClinicalTrials.gov Identifier: NCT03039218
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dornier MedTech Systems

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Dornier Aries 2 Device: Placebo / Sham Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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

Primary Purpose: Treatment
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)
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Subjects assigned to this group will receive Active treatments using the Dornier Aries 2.
Device: Dornier Aries 2
Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

Placebo Comparator: Placebo / Sham
Subjects assigned to this group will receive placebo / sham (no active treatment).
Device: Placebo / Sham
Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction




Primary Outcome Measures :
  1. International Inventory of Erectile Function ("IIEF") [ Time Frame: primary outcome at 3 month follow-up visit ]
    validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials


Other Outcome Measures:
  1. Erectile Hardness Score [ Time Frame: Proportion of patients with an EHS=4 at the 3 month follow-up visit ]
    tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.

  2. Global Assessment Questionnaire ("GAQ"). [ Time Frame: The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit ]
    2 question questionnaire that assesses improvement in symptoms following treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for males with erectile dysfunction
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Radical prostatectomy.
  2. Previous radiation therapy to pelvis.
  3. Previous stem cell or platelet rich plasma therapy.
  4. 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.
  5. Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
  6. Hormone usage, other than testosterone, clomiphene or thyroid medication.
  7. Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
  8. Psychogenic ED.
  9. Peyronie's Disease or penile curvature that negatively influences sexual activity.
  10. Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
  11. 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.
  12. Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
  13. Patients with cardiac or non-cardiac electrical devices implanted.
  14. Anatomical or neurological abnormalities in the treatment area.
  15. Diabetes Mellitus with severe polyneuropathy.
  16. Patients with generalized polyneuropathy irrespective of cause.
  17. Refusal to suspend ED therapy for duration of study.
  18. Men deemed not healthy enough to participate in sexual activity.
  19. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
  20. Average EHS ≤ 2 at baseline assessment following "washout".
  21. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
  22. 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.
  23. Known allergy to ultrasound gel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039218


Contacts
Contact: Mary Butler +49 8153 888 502 mbutler@dornier.com
Contact: John Hoffer 770-514-6163 jhoffer@dornier.com

Locations
United States, California
San Diego Sexual Medicine Recruiting
San Diego, California, United States, 92120
Contact: Irwin Goldstein, MD    619-265-8865    irwingoldstein@sdsm.info   
Contact: Sue Goldstein    619 265-8865    suewgoldstein@gmail.com   
Principal Investigator: Irwin Goldstein, MD         
United States, Nebraska
Adult Pediatric Urology & Urogynecology Recruiting
Omaha, Nebraska, United States, 68114
Contact: Andrew Trainer, MD    402-397-7989    research@adultpediatricuro.com   
Contact: Tara Walia    402-932-6735    twalia@adultpediatricuro.com   
Principal Investigator: Andrew Trainer, MD         
United States, New York
Brooklyn Urology Research Group Recruiting
Brooklyn, New York, United States, 11215
Contact: Ivan Grunberger    718-230-7788    grunbergermd@optonline.net   
Contact: Celeste Egan    718) 230-7788    ceganburg@gmail.com   
Principal Investigator: Ivan Grunberger, MD         
Manhattan Medical Research Recruiting
New York, New York, United States, 10016
Contact: Jed Kaminetsky, MD    212-686-9015    jckammd@att.net   
Contact: Betsy Moclair    917-409-3933    bmoclair@manhattanmedicalresearch.com   
Principal Investigator: Jed Kaminetsky, MD         
Sponsors and Collaborators
Dornier MedTech Systems
Investigators
Principal Investigator: Irwin Goldstein San Diego Sexual Medicine

Publications of Results:
Responsible Party: Dornier MedTech Systems
ClinicalTrials.gov Identifier: NCT03039218     History of Changes
Other Study ID Numbers: G140216 S004
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Dornier MedTech Systems:
erectile dysfunction
shockwave
Dornier

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders