Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy (ESWT)

Odense University Hospital

Status: Suspended

Conditions: Erectile Function

Treatments: Procedure: Extracorporeal Shockwave Terapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03143790

OUHL14.1

Details and patient eligibility

About

Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

Full description

All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy).

Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score).

Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2.

Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment.

For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.

Enrollment: 18 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Erectil dysfunction after radical prostatectomy less than two years ago
• IIEF - less than 20
• EHS - less than 4

Exclusion criteria

• drop out
• not sexual active
• penile prostesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

ESWT

Active Comparator group

Description:

500 shockwave 3 different points on penis bilateral

Treatment:

Procedure: Extracorporeal Shockwave Terapy

Placebo

Placebo Comparator group

Description:

500 shockwave 3 different points on penis bilateral

Treatment:

Procedure: Extracorporeal Shockwave Terapy