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

Erectile Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03039218
• Other study ID #: G140216 S004
• Status: Terminated
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: August 2018
• Source: Dornier MedTech Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Dornier Aries 2
Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
• Placebo / Sham
Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

Locations

Country	Name	City	State
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Manhattan Medical Research	New York	New York
United States	Adult Pediatric Urology & Urogynecology	Omaha	Nebraska
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Dornier MedTech Systems

Country where clinical trial is conducted

United States, 

References & Publications (5)

Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés 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. — View 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. Review. — View 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):1550-5. doi: 10.1016/j.juro.2015 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Erectile Hardness Score	tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.	Proportion of patients with an EHS=4 at the 3 month follow-up visit
Other	Global Assessment Questionnaire ("GAQ").	2 question questionnaire that assesses improvement in symptoms following treatment	The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit
Primary	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