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CompletedNCT03641846Updated May 5, 2022

Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction

An interventional study of DornierAries2 LiST device + 5 mg Tadalafil and DornierAries2 LiST device + Placebo Pill in Erectile Dysfunction and Low Intensity Shockwave Therapy, sponsored by Institute for the Study of Urological Diseases, Greece. Completed at 1 site in Greece. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Institute for the Study of Urological Diseases, Greece · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Male
01

Study summary

This is a randomized, double-blind, 2 parallel arms clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 50 men with vasculogenic ED with primary objective to examine the efficacy of LiST using Aries2 device.

02

Conditions studied

  • Erectile Dysfunction
  • Low Intensity Shockwave Therapy

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03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Institute for the Study of Urological Diseases, Greece is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Consent to participate.
  2. Age 40-70 years.
  3. Sexually active in a stable, heterosexual relationship of more than three months duration.
  4. Presence of Erectile Dysfunction for at least 6 months.
  5. At Screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history
  6. PDE5i users and report some or good response to PDE5i. Last reported PDE5i use must be within 30 days of Screening Visit.
  7. Agree to suspend all other ED therapies, except the assigned study treatments, for the duration of the study.
  8. Agree to attempt sexual intercourse at least 4 times during the last 4 weeks prior to Visit 2/Randomization, 1-month Follow Up, 3-month Follow-Up and 6-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.
  9. IIEF-EF score 17-25 at Visit 2 (after PDE5i washout)
  10. At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis into your partner's vagina?" answered "YES" 50% - 100% of the time.
  11. At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" \< 100% of the time.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
  3. Previous history of priapism or penile fracture
  4. Previous radiation therapy to pelvis.
  5. Abnormal serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
  6. 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.
  7. ED due primarily to psychogenic factors.
  8. Peyronie's Disease or penile curvature that negatively influences sexual activity.
  9. Patients with cardiac or non-cardiac electrical devices implanted.
  10. Open wounds, or any anatomical or neurological abnormalities in the treatment area.
  11. 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).
  12. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
  13. Refusal to suspend alternative ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
  14. Men deemed not healthy enough to participate in sexual activity.
  15. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
  16. 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.
  17. Known allergy to ultrasound gel.
  18. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  19. 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.
  20. 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.
  21. History of adverse events in response to tadalafil, which would prevent the patient from being blinded to his group allocation, and/or prevent patient compliance to the study protocol.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    LiST + 5mg Tadalafil Group

    All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks.

    Other: DornierAries2 LiST device + 5 mg Tadalafil

  • Placebo comparator
    LiST+Placebo Group

    All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily placebo pill. Total treatment period = 4 weeks.

    Other: DornierAries2 LiST device + Placebo Pill

Interventions

  • OtherDornierAries2 LiST device + 5 mg Tadalafil

    All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks

  • OtherDornierAries2 LiST device + Placebo Pill

    All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Placebo pills. Total treatment period = 4 weeks.

06

What researchers measure

Primary outcomes

  1. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

    EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)

    Time frame: baseline and 12-week follow-up visit

Secondary outcomes

  1. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

    EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)

    Time frame: baseline and 4-week follow-up visit

  2. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

    EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)

    Time frame: baseline and 24-week follow-up visit

  3. 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.The Sexual Encounter Profile (SEP) is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"

    Time frame: baseline and 4-week follow-up visit

  4. 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.The Sexual Encounter Profile (SEP) is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"

    Time frame: baseline and 12-week follow-up visit

  5. 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.The Sexual Encounter Profile (SEP) is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"

    Time frame: baseline and 24-week follow-up visit

  6. Number of patients with treatment related adverse events

    Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported

    Time frame: 28 weeks

07

Study locations

1 site
  • G.Gennimatas Hospital
    Thessaloniki, 54621, Greece
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Jan 2021, 28 months.

Of 115 non-industry interventional studies with no phase under Erectile Dysfunction, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 28 months is close to that.

Counting every sponsor, half of 137 studies reached it within 32 months; a quarter within 14 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2018
First posted
Aug 22, 2018
StartActual
Aug 28, 2018
Primary completionActual
Jan 15, 2021
CompletionActual
Apr 16, 2021
Last update
May 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03641846
Lead sponsor
Institute for the Study of Urological Diseases, Greece
Responsible party
Dimitrios Hatzichristou (Chairman, Institute for the Study of Urological Diseases, Greece) — Principal investigator
First posted
Aug 22, 2018
Start date
Aug 28, 2018
Primary completion
Jan 15, 2021
Completion
Apr 16, 2021
Last update
May 5, 2022

Study contacts

Dimitrios Hatzichristou, Prof.
principal investigator · Institute for the Study of Urological Diseases, Thessaloniki, Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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