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Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

Primary Purpose

Erectile Dysfunction

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
shock waves
Sponsored by
Storz Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring IIEF score, ED

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Erectile dysfunction for more than 6 months
  • Informed consent
  • Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
  • IIEF-15 score less than 20
  • No neurological disease
  • Stable partnership for more than 3 months
  • Age 18-75

Exclusion Criteria:

  • Total prostatectomy
  • Another reason for ED except for vascular disorder
  • Clinically significant hematological disease
  • Heart stroke, Arrythmia during the last 6 months
  • Cancer during the last 5 years
  • Intake of antiandrogen
  • ED treatment with the last 7 days
  • IIEF score higher than, equal to 20
  • Previous shockwave treatment

Sites / Locations

  • Bethanien Krankenhaus Chemnitz gemeinnützige GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Shock wave treatment

Placebo Shock wave treatment

Arm Description

Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)

Shock waves are prohibited to enter the body by placebo stand-off.

Outcomes

Primary Outcome Measures

Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)

Secondary Outcome Measures

Quality of erection (Quality of Erection Questionnaire)

Full Information

First Posted
February 19, 2014
Last Updated
March 5, 2015
Sponsor
Storz Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT02068417
Brief Title
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)
Official Title
A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
It has been decided to improve the inclusion criteria for better study outcome
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Storz Medical AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
IIEF score, ED

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shock wave treatment
Arm Type
Active Comparator
Arm Description
Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)
Arm Title
Placebo Shock wave treatment
Arm Type
Placebo Comparator
Arm Description
Shock waves are prohibited to enter the body by placebo stand-off.
Intervention Type
Device
Intervention Name(s)
shock waves
Other Intervention Name(s)
ESWT, extracorporeal shock wave therapy
Intervention Description
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Primary Outcome Measure Information:
Title
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
Time Frame
up to 6 months post treatment
Secondary Outcome Measure Information:
Title
Quality of erection (Quality of Erection Questionnaire)
Time Frame
At screening, 1, 3 and 6 months post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Erectile dysfunction for more than 6 months Informed consent Positive effect of phosphodiesterase type 5 inhibitor (PDE5i) IIEF-15 score less than 20 No neurological disease Stable partnership for more than 3 months Age 18-75 Exclusion Criteria: Total prostatectomy Another reason for ED except for vascular disorder Clinically significant hematological disease Heart stroke, Arrythmia during the last 6 months Cancer during the last 5 years Intake of antiandrogen ED treatment with the last 7 days IIEF score higher than, equal to 20 Previous shockwave treatment
Facility Information:
Facility Name
Bethanien Krankenhaus Chemnitz gemeinnützige GmbH
City
Chemnitz
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

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