Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction. (ESWTvsED)
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ClinicalTrials.gov Identifier: NCT02063061 |
Recruitment Status :
Completed
First Posted : February 14, 2014
Last Update Posted : December 28, 2016
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Condition or disease | Intervention/treatment | Phase |
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Erectile Dysfunction | Device: Sham treatment Device: ESWT treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction. |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
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Sham Comparator: Sham treatment
Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again.
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Device: Sham treatment
Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.
Other Name: Sham Device: ESWT treatment ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Other Name: ESWT |
Active Comparator: ESWT treatment
Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
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Device: ESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Other Name: ESWT |
- International Index of Erectile Function (IIEF) outcome increases by 5 points [ Time Frame: 1 year ]
- Erectile Hardness Scale (EHS) outcome is equal or higher than 3. [ Time Frame: 1 year ]
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome [ Time Frame: 18 weeks ]Assesed after complition af clinical trial
- Number of Participants with Adverse Events [ Time Frame: 18 weeks ]During treatment period all patients will be examined for advers events

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Erectile dysfunction for at least 6 months
- In relationships
- Patient accept not to use any other therapy against erectile dysfunction
Exclusion Criteria:
- Prostatectomy
- Radiotherapy in pelvis
- Hormonal therapy against prostate cancer
- Anatomical penis disorder
- Penile prosthesis
- Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
- Psychiatric disorder
- Hypogonadism
- IIEF score higher than 25
- Pregnant partner og delivered within last 12 months
- Critical health disease
- Neurological disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063061
Denmark | |
Hospital of Southern Denmark | |
Sonderborg, Southern Denmark, Denmark, 6400 |
Study Director: | Palle Oshter, professor | University of Southern Denmark |
Publications of Results:
Responsible Party: | Grzegorz Fojecki, MD, University of Southern Denmark |
ClinicalTrials.gov Identifier: | NCT02063061 |
Other Study ID Numbers: |
CIV-13-07-011546 |
First Posted: | February 14, 2014 Key Record Dates |
Last Update Posted: | December 28, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
extracorporeal shock wave therapy ESWT erectile dysfunction |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |