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

Not Applicable

Suspended

• Conditions: Erectile Function
• Interventions: Procedure: Extracorporeal Shockwave Terapy

• Registration Number: NCT03143790
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-07
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-08
• Last Update Posted: 2017-05-08
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

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

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Exclusion Criteria

• drop out
• not sexual active
• penile prostesis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Extracorporeal Shockwave Terapy	500 shockwave 3 different points on penis bilateral
ESWT	Extracorporeal Shockwave Terapy	500 shockwave 3 different points on penis bilateral

Primary Outcome Measures

Name	Time	Method
IIEF-5 point	1, 3 and 6 months	Change in IIEF-5 point

Trial Locations

Locations (1)

OUH; 🇩🇰 Odense, Denmark