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Clinical Trials/NCT03143790
NCT03143790
Suspended
Not Applicable

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

Odense University Hospital1 site in 1 country18 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erectile Function
Sponsor
Odense University Hospital
Enrollment
18
Locations
1
Primary Endpoint
IIEF-5 point
Status
Suspended
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martha Haahr M.D

M.D

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • not sexual active
  • penile prostesis

Outcomes

Primary Outcomes

IIEF-5 point

Time Frame: 1, 3 and 6 months

Change in IIEF-5 point

Study Sites (1)

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