Erectile DysfunctionPhase 3NCT02068417
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)
A Phase 3 study testing shock waves in people with Erectile Dysfunction, run by Storz Medical AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- shock waves
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 3
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- ED treatment with the last 7 days
- IIEF score higher than, equal to 20
- Previous shockwave treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
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.
- Conditions
- Erectile Dysfunction
- Being tested
- shock waves
- Keywords
- IIEF score, ED
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wavesDevice
Also called ESWT, extracorporeal shock wave therapy
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
| Study group | Role | What they receive |
|---|---|---|
| Shock wave treatment | Active comparator | Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2) Receives: Device: shock waves |
| Placebo Shock wave treatment | Placebo comparator | Shock waves are prohibited to enter the body by placebo stand-off. Receives: Device: shock waves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
Measured: up to 6 months post treatment
Secondary outcomes (1)
Quality of erection (Quality of Erection Questionnaire)
Measured: At screening, 1, 3 and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: It has been decided to improve the inclusion criteria for better study outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Storz Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068417
- Sponsor's protocol ID
- STU10/002
- Status last verified
- Mar 2015
- First submitted
- 19 Feb 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
- ClinicalTrials.gov ID
- NCT02068417
- Acronym / sponsor ID
- STU10/002
- Conditions
- Erectile Dysfunction
- Keywords
- IIEF score, ED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It has been decided to improve the inclusion criteria for better study outcome
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Storz Medical AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock wave treatment | Active comparator | Device: shock wavesShock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2) |
| Placebo Shock wave treatment | Placebo comparator | Device: shock wavesShock waves are prohibited to enter the body by placebo stand-off. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| shock wavesAlso: ESWT, extracorporeal shock wave therapyextracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off | Device | Placebo Shock wave treatment, Shock wave treatment |
Primary outcome
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
Time frame: up to 6 months post treatment
1 secondary outcome
Quality of erection (Quality of Erection Questionnaire)
Time frame: At screening, 1, 3 and 6 months post treatment
Results and safety
The study was stopped early (reason given: It has been decided to improve the inclusion criteria for better study outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing shock waves in people with Erectile Dysfunction, run by Storz Medical AG at 1 site in Germany.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Mar 2015. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It has been decided to improve the inclusion criteria for better study outcome). Results are not available in the source record.
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?
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire) (time frame: up to 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.