Erectile DysfunctionNCT03741439
RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction
A study testing Treatment in people with Erectile Dysfunction and Endothelial Dysfunction, run by IVI Santiago de Chile at 1 site in Chile.
Trial summary
Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Endothelial Dysfunction
- What is being tested?
- Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChile
- Study dates
- 17 Jan 2018to 2 Jan 2019
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild/moderate erectile dysfunction
- Good response to any phospodiesterase inhibitor
Who cannot join
- No history of erectile dysfunction
- No decompensated diabetes
- No untreated hypogonadism
- No severe erectile dysfunction
Trial locations and contacts
1 site in 1 country.
Marcelo Marconi, MD contact
Chile1 site, 1 recruiting
- Recruiting
Unidad de Andrologia - Red Salud UC/Christus
Santiago, Santiago Metropolitan, RM
Marcelo Marconi, MD, +56979685115, mmarconi@andro.cl
Marcelo Marconi, MD, +56979685115, info@andro.cl
About this study
Official title: Randomized Controlled Trial to Test Low Intensity Shockwave Treatment in Patients With Mild and Moderate Erectile Dysfunction Using a Electromagnetic Emitter
Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Different types of: shockwave generators, treatment protocols and ED severities of patients included in the studies, explain the lack of recommendations for a standard treatment. Ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations.
Objective: to test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.
Read more
Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.
After ending T3 we expect to treat placebo patients to see impact of changing arm study.
Read the detailed description
We are test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.
Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.
After ending T3 we expect to treat placebo patients to see impact of changing arm study.
- Conditions
- Erectile Dysfunction, Endothelial Dysfunction
- Being tested
- Treatment, Sham
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDevice
Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter
ShamDevice
Sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Receives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter. Receives: Device: Treatment |
| Sham Arm | Sham comparator | Receives sham treatment with same applicator, same sound, same time and number of shocks. But no real energy is delivered. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in IIEF-5
We expect a change of 3.5 points in the IIEF-5 score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start17 Jan 2018
- Primary completion2 Nov 2018
- Study completion2 Jan 2019 (estimated)
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
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Santiago de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile
- Responsible party
- Sponsor
- Investigators
- Marcelo Marconi, MD, Principal investigator, Asistant Professor Urology Department Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741439
- Sponsor's protocol ID
- Marconi01
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are evaluating is we decide to share all the protocol. All the protocol will be published with the results.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Test Low Intensity Shockwave Treatment in Patients With Mild and Moderate Erectile Dysfunction Using a Electromagnetic Emitter
- ClinicalTrials.gov ID
- NCT03741439
- Acronym / sponsor ID
- Marconi01
- Conditions
- Erectile Dysfunction, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- IVI Santiago de ChileUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Jan 2019 (estimated)
- First posted
- 14 Nov 2018 (actual)
- 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.
Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Different types of: shockwave generators, treatment protocols and ED severities of patients included in the studies, explain the lack of recommendations for a standard treatment. Ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations.
Objective: to test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.
Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.
After ending T3 we expect to treat placebo patients to see impact of changing arm study.
Detailed description
We are test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.
Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.
After ending T3 we expect to treat placebo patients to see impact of changing arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: TreatmentReceives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter. |
| Sham Arm | Sham comparator | Device: ShamReceives sham treatment with same applicator, same sound, same time and number of shocks. But no real energy is delivered. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild/moderate erectile dysfunction
- Good response to any phospodiesterase inhibitor
Key exclusion criteria (4 listed)
- No history of erectile dysfunction
- No decompensated diabetes
- No untreated hypogonadism
- No severe erectile dysfunction
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 |
|---|---|---|
| TreatmentLow intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter | Device | Treatment arm |
| ShamSham treatment | Device | Sham Arm |
Primary outcome
Changes in IIEF-5
Time frame: 12 weeks
We expect a change of 3.5 points in the IIEF-5 score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Undecided. We are evaluating is we decide to share all the protocol. All the protocol will be published with the results.
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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.
Marcelo Marconi, MD contact
Marcelo Marconi, MD principal investigator
Asistant Professor Urology Department Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Erectile Dysfunction and Endothelial Dysfunction, run by IVI Santiago de Chile at 1 site in Chile.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo Marconi, MD (+56979685115, mmarconi@andro.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IIEF-5 (time frame: 12 weeks). 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 14 Nov 2018.