The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders (LI-ESWT)

Rambam Health Care Campus

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Device: LI-ESWT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01272297

shock wave III

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

LI-ESWT

Experimental group

Description:

Low intensity shock wave treatment- 12 sessions

Treatment:

Device: LI-ESWT