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
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring IIEF score, ED
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
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
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)
We'll reach out to this number within 24 hrs