The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- IIEF-ED Domain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LI-ESWT
Low intensity shock wave treatment- 12 sessions
Intervention: LI-ESWT (Device)
Outcomes
Primary Outcomes
IIEF-ED Domain score
Time Frame: 17 weeks after first visit
Change of 5 points and above in IIEF-ED Domain score
Secondary Outcomes
- Rigidity scale(17 weeks after first visit)