Erectile DysfunctionESWTvsEDNCT02063061
Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
A study testing ESWT treatment in people with Erectile Dysfunction, run by Grzegorz Fojecki at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- ESWT treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction for at least 6 months
- In relationships
- Patient accept not to use any other therapy against erectile dysfunction
Who cannot join
- Prostatectomy
- Radiotherapy in pelvis
- Hormonal therapy against prostate cancer
- Anatomical penis disorder
- Penile prosthesis
- Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
Show all 12Show fewer
- Psychiatric disorder
- Hypogonadism
- IIEF score higher than 25
- Pregnant partner og delivered within last 12 months
- Critical health disease
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.
Read the detailed description
Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.
- Conditions
- Erectile Dysfunction
- Being tested
- Sham treatment, ESWT treatment
- Keywords
- extracorporeal shock wave therapy ESWT, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham treatmentDevice
Also called Sham
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.
ESWT treatmentDevice
Also called ESWT
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham treatment | Sham comparator | 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. Receives: Device: Sham treatment; Device: ESWT treatment |
| ESWT treatment | Active comparator | Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again. Receives: Device: ESWT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF) outcome increases by 5 points
Measured: 1 year
Secondary outcomes (1)
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grzegorz Fojecki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Responsible party
- Sponsor-investigator, Grzegorz Fojecki, University of Southern Denmark
- Investigators
- Palle Oshter, professor, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063061
- Sponsor's protocol ID
- CIV-13-07-011546
- Acronym
- ESWTvsED
- Status last verified
- Dec 2016
- First submitted
- 9 Jan 2014
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696.
PubMed 23554844Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.
PubMed 22008059Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
PubMed 20451317
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT02063061
- Acronym / sponsor ID
- ESWTvsED / CIV-13-07-011546
- Conditions
- Erectile Dysfunction
- Keywords
- extracorporeal shock wave therapy ESWT, erectile dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Grzegorz FojeckiUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.
Detailed description
Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham treatment | Sham comparator | Device: Sham treatment, Device: ESWT treatmentSubject 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. |
| ESWT treatment | Active comparator | Device: ESWT treatmentSubject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Erectile dysfunction for at least 6 months
- In relationships
- Patient accept not to use any other therapy against erectile dysfunction
Key exclusion criteria (12 listed)
- Prostatectomy
- Radiotherapy in pelvis
- Hormonal therapy against prostate cancer
- Anatomical penis disorder
- Penile prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham treatmentAlso: ShamPatients 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. | Device | Sham treatment |
| ESWT treatmentAlso: ESWTESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks. | Device | ESWT treatment, Sham treatment |
Primary outcome
International Index of Erectile Function (IIEF) outcome increases by 5 points
Time frame: 1 year
1 secondary outcome
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Results publication: PubMed 23554844Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696.
- Results publication: PubMed 22008059Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.
- Results publication: PubMed 20451317Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
- regional ethical committeeLink provided by the sponsor.
- University of Southern DenmarkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Palle Oshter, professor study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT treatment in people with Erectile Dysfunction, run by Grzegorz Fojecki at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) outcome increases by 5 points (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063061, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016; AzTrials last refreshed its copy on 5 Nov 2026.