Linear Focused Shockwave Treatment for Erectile Dysfunction

Initia

Status: Terminated

Conditions: Vasculogenic Erectile Dysfunction

Treatments: Device: Renova

Study type: Interventional

Funder types: Industry

Identifiers

NCT02152683

LISW-NY

Details and patient eligibility

About

The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Enrollment: 84 patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Good general health
2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
5. Stable sexual relationship for at least 3 months prior to treatment
6. Minimum of two sexual attempts per month

Exclusion criteria

1. Hormonal, neurological or psychological pathology
2. Past radical prostatectomy or extensive pelvic surgery
3. Recovering from cancer during last year
4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
5. Clinically significant chronic hematological disease
6. Anti-androgens, oral or injectable androgens
7. Past radiotherapy treatment of the pelvic region
8. International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

long protocol

Experimental group

Description:

Renova

Treatment:

Device: Renova

short protocol

Experimental group

Description:

Renova

Treatment:

Device: Renova