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

R

Rambam Health Care Campus

Status and phase

Unknown
Phase 3

Conditions

Erectile Dysfunction

Treatments

Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
Device: Low intensity shock wave therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01262157
507-10 RMB

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

placebo
Sham Comparator group
Description:
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Treatment:
Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
Shock wave therapy
Active Comparator group
Description:
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
Treatment:
Device: Low intensity shock wave therapy

Trial contacts and locations

0

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Central trial contact

Yoram Vardi, Prof; Ilan Gruenwald, MD

Data sourced from clinicaltrials.gov

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