Clinical trial NCT01272297: The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders
Official title: The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: LI-ESWT
Erectile Dysfunction
Non PDE5 inhibitor responders
Shock wave
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Medispec
First posted: 2011-01-07
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.

Detailed description: We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that 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. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: IIEF-ED Domain score
timeFrame: 17 weeks after first visit
Secondary outcomes:
measure: rigidity scale
timeFrame: 17 weeks from visit 1
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Yoram Vardi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Ilan Gruenwald, MD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Boaz Appel, MD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Ezra Gerber, RN
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Yaron Ofer, MD
role: STUDY_DIRECTOR
affiliation: Rambam Health Care Campus
name: Omar Massarwa, RN
role: STUDY_DIRECTOR
References: