The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i (LI-ESWT)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication|
- 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
- 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
|Study Start Date:||February 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Low intensity shock wave treatment- 12 sessions
Low intensity shock wave treatment - 12 sessions
Other Name: Omnispec model ED1000
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.