The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i (LI-ESWT)

This study has been completed.
Sponsor:
Collaborator:
Medispec
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01274949
First received: January 9, 2011
Last updated: September 13, 2011
Last verified: September 2011

January 9, 2011
September 13, 2011
February 2010
July 2011   (final data collection date for primary outcome measure)
IIEF-ED Domain score [ Time Frame: 17 weeks after first visit ] [ Designated as safety issue: No ]
Change of 5 points and above in IIEF-ED Domain score
Same as current
Complete list of historical versions of study NCT01274949 on ClinicalTrials.gov Archive Site
Rigidity scale [ Time Frame: 17 weeks after first visit ] [ Designated as safety issue: No ]
a change to 3 or 4 points in the rigidty scale
Same as current
Not Provided
Not Provided
 
The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i
The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication

Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

We included severe ED patients that underwent radical prostatectomy at least one year previously and failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy. Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. This study further emphasises the need to study specific populations with unique etiologies causing ED.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Erectile Dysfunction
Device: LI-ESWT
Low intensity shock wave treatment - 12 sessions
Other Name: Omnispec model ED1000
Experimental: LI-ESWT
Low intensity shock wave treatment- 12 sessions
Intervention: Device: LI-ESWT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Post Radical prostatectomy
  • ED of more than 6 months
  • Rigidity score ≤ 2 during PDE5i therapy
  • Stable heterosexual relationship for more than 3 months
  • Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

  • Prior surgery or radiotherapy in pelvic region
  • Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Cardiovascular conditions that prevent sexual activity
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01274949
3060 radical
Yes
Rambam Health Care Campus
Rambam Health Care Campus
Medispec
Study Director: Ilan Gruenwald, MD Rambam Medical Investigator
Rambam Health Care Campus
September 2011

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