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

Erectile Function Clinical Trial

— ESWT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03143790
• Other study ID #: OUHL14.1
• Status: Suspended
• Phase: N/A
• First received: August 7, 2014
• Last updated: May 4, 2017
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 18
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Function

Intervention

Procedure:
• Extracorporeal Shockwave Terapy
Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter

Locations

Country	Name	City	State
Denmark	OUH	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-5 point	Change in IIEF-5 point	1, 3 and 6 months