Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
This study is currently recruiting participants.
Verified December 2012 by Rambam Health Care Campus
Sponsor:
Rambam Health Care Campus
Information provided by (Responsible Party):
i_gruenwald, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01317693
First received: March 8, 2011
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Device: Low intensity shock waves |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction |
Resource links provided by NLM:
Further study details as provided by Rambam Health Care Campus:
Primary Outcome Measures:
- Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rigidity Score Questionaire- an increase by at least 1 point is considered success [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment LI-ESWT
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
|
Device: Low intensity shock waves
1500 shocks, Energy Density - 0.09 mJ/mm2
Other Name: Omnispec model ED1000
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ED of more than 6 months
- At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
- Positive response to PDE-5 inhibitors
- IIEF-5 domain score of 12-20 denoting mild to severe ED
- Non-Neurological pathology
- Stable heterosexual relationship for more than 3 months
Exclusion Criteria:
- NPT - normal/flat
- Prior prostatectomy surgery
- Any cause of ED other than vascular related
- Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Cardiovascular conditions that prevent sexual activity
- History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
- Cancer within the past 5 years.
- Anti-androgens, oral or injectable androgens
- Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317693
Contacts
| Contact: Ilan Gruenwald, MD | 00972-4-8542882 | i_gruenwald@rambam.health.gov.il |
Locations
| Israel | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Ilan Gruenwald, MD 00972-4-8542882 i_gruewald@rambam.health.gov.il | |
| Principal Investigator: Yoram Vardi, Prof. | |
| Principal Investigator: Ilan Gruenwald, MD | |
| Sub-Investigator: Boaz Appel, MD | |
| Sub-Investigator: Yaron Ofer, MD | |
| Sub-Investigator: Suliman Nassar, MD | |
| Sub-Investigator: Omar Massarwa, RN BA | |
| Sub-Investigator: Ezra Gerber, RN BA | |
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
| Principal Investigator: | Ilan Gruenwald, MD | Rambam Health Care Campus |
| Study Director: | Yoram Vardi, Prof. | Rambam Health Care Campus |
More Information
No publications provided
| Responsible Party: | i_gruenwald, MD, Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01317693 History of Changes |
| Other Study ID Numbers: | 0571-10-RMB |
| Study First Received: | March 8, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
LI-ESWT Erectile Dysfunction ED Shock waves Therapy |
Additional relevant MeSH terms:
|
Shock Erectile Dysfunction Pathologic Processes Sexual Dysfunction, Physiological |
Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013