Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
i_gruenwald, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01317680
First received: March 8, 2011
Last updated: May 23, 2012
Last verified: May 2012

March 8, 2011
May 23, 2012
March 2011
March 2013   (final data collection date for primary outcome measure)
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01317680 on ClinicalTrials.gov Archive Site
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)
Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)

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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erectile Dysfunction
  • Device: Omnispec model ED1000
    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: Sham control
    We use the same probe that induces the same sensation on the penis and the same noise yet no energy
  • Active Comparator: 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.
    Intervention: Device: Omnispec model ED1000
  • Placebo Comparator: Sham control
    We use the same probe that induces the same sensation on the penis and the same noise yet no energy.
    Intervention: Device: Sham control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prior prostatectomy surgery
  • ED of more than 6 months
  • Rigidity score < 3 during PDE5i therapy
  • Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Radiotherapy in pelvic region
Male
18 Years to 80 Years
No
Israel
 
NCT01317680
0037-11-RMB
No
i_gruenwald, Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Not Provided
Rambam Health Care Campus
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP