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

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: LI-ESWT

• Registration Number: NCT01272297
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LI-ESWT	LI-ESWT	Low intensity shock wave treatment- 12 sessions

Primary Outcome Measures

Name	Time	Method
IIEF-ED Domain score	17 weeks after first visit	Change of 5 points and above in IIEF-ED Domain score

Secondary Outcome Measures

Name	Time	Method
rigidity scale	17 weeks from visit 1	a change to 3 or 4 points in the rigidty scale