Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

NCT01262157 | Unknown Phase 3 DMC

• 1 other identifier: 507-10 RMB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; PDE5 Inhibitor; Low intensity shock wave therapy.

Outcome Measures

Primary Outcomes (1)

• IIEF-ED Domain

  A change of 5 points or more will indicate success

  17 weeks

Secondary Outcomes (1)

• rigidity score

  17 weeks

Study Arms (2)

placebo

SHAM COMPARATOR

We use the same probe that induces the same sensation on the penis and the same noise yet no energy

Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)

Shock wave therapy

ACTIVE COMPARATOR

12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment

Device: Low intensity shock wave therapy

Interventions

Extracorporeal Shockwave Therapy Generator (Vascuspec) DEVICE

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Also known as: Low intensity shock wave Therapy, Extracorporeal Shockwave Therapy

placebo

Low intensity shock wave therapy DEVICE

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Also known as: Low Intensity Extra Corporal Shock Wave Therapy

Shock wave therapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED of more than 6 months
• Rigidity score \< 3 during PDE5i therapy
• SHIM \<21 during PDE5i therapy
• Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

You may not qualify if:

• Prior prostatectomy surgery
• Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
• Clinically significant chronic hematological disease
• Anti-androgens, oral or injectable androgens
• Radiotherapy in pelvic region

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yoram Vardi, prof

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram Vardi, Prof

CONTACT

++97248542819; yvardi@rambam.health.gov.il

Ilan Gruenwald, MD

CONTACT

++97248542819; i_gruenwald@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2010
• First Posted: December 17, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 19, 2011

Record last verified: 2010-05

Locations

IL (1)