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Erectile DysfunctionNCT03518983

Low-intensity Shockwaves Therapy for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

A study testing Dornier Aries2 device in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35… Read more about this study

Who is it for?
Ages 40 to 70 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Dornier Aries2 device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteGreece
Study dates
22 May 2018to 15 Nov 2021
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

  • Consent to participate.
  • Age 40-70 years.
  • Sexually active in a stable, heterosexual relationship of more than three months duration.
  • Presence of Erectile Dysfunction for at least 6 months.
  • At Screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history
  • PDE5i users and report some or good response to PDE5i. Last reported PDE5i use must be within 30 days of Screening Visit.
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  • Agree to suspend all ED therapy for the duration of the study.
  • Agree to attempt sexual intercourse at least 4 times during the last 4 weeks prior to Visit 2/Randomization, 1-month Follow Up and 3-month Follow-Up without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary.
  • At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis into your partner's vagina?" answered "YES" 25% - 100% of the time.
  • At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" 0% - 50% of the time.
  • At Visit 2, IIEF-EF score 11 - 16.
  • 13. At Visit 2, IIEF Q3 score 2 - 5. 14. At Visit 2, IIEF Q4 score 1 - 3.

Who cannot join

  • Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included.
  • Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
  • Previous history of priapism or penile fracture
  • Previous radiation therapy to pelvis.
  • Abnormal serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
  • Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
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  • ED due primarily to psychogenic factors
  • Peyronie's Disease or penile curvature that negatively influences sexual activity.
  • Patients with cardiac or non-cardiac electrical devices implanted.
  • Open wound or any anatomical or neurological abnormalities in the treatment area.
  • Uncontrolled diabetes mellitus with glucose >200 mg/dL (once or more times/week during the last month prior to recruitment, or during screening blood test).
  • Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
  • Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
  • Men deemed not healthy enough to participate in sexual activity.
  • Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
  • Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
  • Known allergy to ultrasound gel.
  • History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  • Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using SSRI or psychotropic medications e.g., Citalopram (Celexa), Escitalopram (Lexapro, Cipralex), Paroxetine (Paxil, Seroxat), Fluoxetine (Prozac), Fluvoxamine (Luvox, Faverin),Sertraline (Zoloft, Lustral), Clonazepam (Klonopin), Alprazolam (Xanax), Aripiprazole (Ambilify), Clozapine (Clozaril), Risperidone (Risperdal), Quetiapine (Seroquel), Olanzapine (Zyprexa) are also excluded.
  • Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • G.Gennimatas Hospital

    Thessaloniki, 54621

Other trials in Greece

About this study

Official title: Low-intensity Shockwaves Therapy: Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

Being tested
Dornier Aries2 device, Dornier Aries2 device (sham probe)
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dornier Aries2 deviceDevice

    The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites).

  • Dornier Aries2 device (sham probe)Device

    The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe.

Study groups in NCT03518983
Study groupRoleWhat they receive
Sham GroupSham comparatorThe subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) by the sham probe.
Receives: Device: Dornier Aries2 device (sham probe)
Active GroupActive comparatorThe subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) at energy level 7.
Receives: Device: Dornier Aries2 device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference between the 2 groups in the percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF

    MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline

    Measured: at 3 month follow up visit

Secondary outcomes (3)

  1. The difference between the 2 groups in the change of the EF domain score of the IIEF

    EF domain of the IIEF questionnaire will be completed

    Measured: baseline and 3 month follow up visit.

  2. Change in Sexual Encounter Profile Question 3 (SEP3) score

    The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported

    Measured: baseline and 3 month follow up visit.

  3. Number of patients with treatment related adverse events

    Potential treatment related adverse events after the first LI-ESWT session and during the 3 month follow up period will be reported

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start22 May 2018
  3. Primary completion15 Nov 2021
  4. Study completion15 Nov 2021

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518983
Sponsor's protocol ID
5142/2-4-18
Status last verified
May 2022
First submitted
26 Apr 2018
Last updated
5 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.

    PubMed 29396020

  • Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.

    PubMed 28673433

Questions about this trial

What is this clinical trial studying?

A study testing Dornier Aries2 device in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.

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 12 inclusion and 20 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 5 May 2022. 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 Greece. 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?

The difference between the 2 groups in the percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF (time frame: at 3 month follow up visit). 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 NCT03518983, which also lists 2 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 5 May 2022.

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