NCT01272297

The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.

Detailed description

We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that 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. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	LI-ESWT	Low intensity shock wave treatment - 12 sessions

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2011-01-07
• Last updated: 2012-12-19