Erectile DysfunctionNCT03006536
Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
A study testing Li-ESWT in people with Erectile Dysfunction, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Li-ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 13 Mar 2022
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- A history of erectile dysfunction for >6 months
- IIEF-ED score < 25
- In a stable heterosexual relationship for at least 6 months
- Willingness to attempt sexual intercourse at least twice per week during the study and follow-up
Who cannot join
- Psychogenic ED as assessed by a standardized interview (attachment 2)
- Known psychiatric illness
- Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke)
- Traumatic nerve injury
- Previous pelvic surgery or radiation
- Heart disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease
Show all 14Show fewer
- Endocrine disease including hypogonadism (total testosterone <12 nmol/l)
- Insulin dependent or uncontrolled diabetes mellitus
- Dependence on erectogenic aids other than PDE5-Inhibitors
- Use of medications which have been shown to interfere with erections
- Use of anticoagulant medications other than low dose aspirin
- Active cancer
- A diagnoses of Peyronie's disease and/or prior occurrence of priapism
- Alcohol abuse (more than 21 containers of alcohol per week)
Trial locations and contacts
1 site in 1 country.
About this study
The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).
- Conditions
- Erectile Dysfunction
- Being tested
- Li-ESWT
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Li-ESWTDevice
Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
| Study group | Role | What they receive |
|---|---|---|
| Li-ESWT | Experimental | Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions Receives: Device: Li-ESWT |
| Sham | Sham comparator | Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions Receives: Device: Li-ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start1 Oct 2017
- Primary completion13 Mar 2022
- Study completion13 Mar 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006536
- Sponsor's protocol ID
- SJ-590
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2016
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
- ClinicalTrials.gov ID
- NCT03006536
- Acronym / sponsor ID
- SJ-590
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 30 Dec 2016 (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 proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Li-ESWT | Experimental | Device: Li-ESWTParticipants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions |
| Sham | Sham comparator | Device: Li-ESWTParticipants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- A history of erectile dysfunction for >6 months
- IIEF-ED score < 25
- In a stable heterosexual relationship for at least 6 months
- Willingness to attempt sexual intercourse at least twice per week during the study and follow-up
Key exclusion criteria (14 listed)
- Psychogenic ED as assessed by a standardized interview (attachment 2)
- Known psychiatric illness
- Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke)
- Traumatic nerve injury
- Previous pelvic surgery or radiation
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 |
|---|---|---|
| Li-ESWTParticipants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions | Device | Li-ESWT, Sham |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: 1 months
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 30 Jan 2024.
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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 study testing Li-ESWT in people with Erectile Dysfunction, run by Zealand University Hospital 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 5 inclusion and 14 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 30 Jan 2024. 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) (time frame: 1 months). 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 30 Jan 2024.