NCT01442077

Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Male
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.

Detailed description

At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form, and will be asked about general medical condition and any problems related to sexual dysfunction. Than the patient's sexual function will be assessed by sexual function questionnaires. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. During the visit, the patient will be assigned to one arm of the study (random), and by the arm he belongs he will receive an explanation about this procedure. Then shall obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), then it would be the first visit. At the first visit (Visit 1) The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of the visit 1 the patient will begin treatment series and will continue to study under the arm belongs, as described: 1.Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). 2.Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. 3.Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). 4.Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments). Four weeks after the treatment series ends the patient will come for another visit will be asked to fill in questionnaires and perform the FMD test again.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)	Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
DEVICE	Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)	Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.
DEVICE	Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)	Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).
DEVICE	Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)	Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2011-09-28
• Last updated: 2012-01-18

Locations

1 site across 1 country: Israel