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

Erectile Dysfunction Clinical Trial

— LI-ESWT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272297
• Other study ID #: shock wave III
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2010
• Last updated: December 18, 2012
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2012
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• LI-ESWT
Low intensity shock wave treatment - 12 sessions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Medispec

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-ED Domain score	Change of 5 points and above in IIEF-ED Domain score	17 weeks after first visit	No
Secondary	rigidity scale	a change to 3 or 4 points in the rigidty scale	17 weeks from visit 1	No