A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- IIEF-ED Domain
Study Overview
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).
Detailed Description
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
placebo
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Intervention: Extracorporeal Shockwave Therapy Generator (Vascuspec) (Device)
Shock wave therapy
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
Intervention: Low intensity shock wave therapy (Device)
Outcomes
Primary Outcomes
IIEF-ED Domain
Time Frame: 17 weeks
A change of 5 points or more will indicate success
Secondary Outcomes
- rigidity score(17 weeks)