The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i

The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274949

Acronym

LI-ESWT

Enrollment

Registered

2011-01-12

Start date

2010-02-28

Completion date

2011-08-31

Last updated

2011-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

LI-ESWT, Erectile Dysfunction, Radical Prostatectomy, Non PDE5 inhibitor responders, Shock wave

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.

Interventions

DEVICELI-ESWT

Low intensity shock wave treatment - 12 sessions

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
IIEF-ED Domain score	17 weeks after first visit	Change of 5 points and above in IIEF-ED Domain score

Secondary

Measure	Time frame	Description
Rigidity scale	17 weeks after first visit	a change to 3 or 4 points in the rigidty scale

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026