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

Primary Purpose

Erectile Function

Status
Suspended
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Extracorporeal Shockwave Terapy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Function focused on measuring Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • OUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ESWT

Placebo

Arm Description

500 shockwave 3 different points on penis bilateral

500 shockwave 3 different points on penis bilateral

Outcomes

Primary Outcome Measures

IIEF-5 point
Change in IIEF-5 point

Secondary Outcome Measures

Full Information

First Posted
August 7, 2014
Last Updated
May 4, 2017
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03143790
Brief Title
Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
Acronym
ESWT
Official Title
Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Suspended
Why Stopped
Capacity problems
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Function
Keywords
Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to active or placebo treatment.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patient and therapist are blind. Primary investigator is not blind. Unblinding occurs 3 months after the end of treatment
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESWT
Arm Type
Active Comparator
Arm Description
500 shockwave 3 different points on penis bilateral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 shockwave 3 different points on penis bilateral
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shockwave Terapy
Other Intervention Name(s)
ESWT
Intervention Description
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
Primary Outcome Measure Information:
Title
IIEF-5 point
Description
Change in IIEF-5 point
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only humans with a penis
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
OUH
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All results will be published

Learn more about this trial

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

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