The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i

NCT ID: NCT01274949

Last Updated: 2011-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-08-31

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 LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

Detailed Description

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LI-ESWT

Low intensity shock wave treatment- 12 sessions

Group Type: EXPERIMENTAL

LI-ESWT

Intervention Type: DEVICE

Low intensity shock wave treatment - 12 sessions

Interventions

LI-ESWT

Low intensity shock wave treatment - 12 sessions

Intervention Type: DEVICE

Other Intervention Names

Omnispec model ED1000

Eligibility Criteria

Inclusion Criteria

• Post Radical prostatectomy
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medispec

INDUSTRY

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilan Gruenwald, MD

Role: STUDY_DIRECTOR

Rambam Medical Investigator

Locations

neuro-urology unit, Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

3060 radical

Identifier Type: -

Identifier Source: org_study_id