The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- International Index of Erectile function- Erectile Function Domain
Study Overview
Brief Summary
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
Detailed Description
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ED of more than 6 months
- •Rigidity score ≥ 3 under PDE5i therapy
- •SHIM ≤21 under 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
shock wave treatment
Intervention: "MEDISPEC" treatment probe (Device)
"MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Intervention: "MEDISPEC" treatment probe (Device)
Outcomes
Primary Outcomes
International Index of Erectile function- Erectile Function Domain
Time Frame: At screening and 17 weeks later at last visit
An increase in score of 5points and above will be considered success.
Secondary Outcomes
- Rigidity scale(At screening and 17 weeks later at last visit)
- Flow Mediated Dilatation Technique(At screening and 17 weeks later at last visit)