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Status unknownNCT03642366Updated May 5, 2022

Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction

An interventional study of Dornier Aries2 LiST Device + 5mg Tadalafil (1) and Dornier Aries2 LiST Device + 5mg Tadalafil (2) in Erectile Dysfunction, sponsored by Institute for the Study of Urological Diseases, Greece. Status unknown 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

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Male
01

Study summary

This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Low Intensity Shockwave Therapy
03

In context

Erectile Dysfunction

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

This study's planned enrollment of 51 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. Partial response to highest dose of PDE5i
  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 and document the outcome using the Sexual Encounter Profile (SEP) at least 4 times for the last 4 weeks prior to Visit 2/Randomization, 1 month Follow Up, 3 month Follow Up and 4 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-ED score 1-10 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" 0 - 50% of the time.
  11. At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" 0 - 25% 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 wound 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 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,. 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.
  1. 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.
  1. History of adverse events in response to tadalafil, which would 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
51 participants (estimated)

Study arms

  • Active comparator
    Active Arm 1

    Other: Dornier Aries2 LiST Device + 5mg Tadalafil (1)

  • Active comparator
    Active Arm 2

    Other: Dornier Aries2 LiST Device + 5mg Tadalafil (2)

  • Sham comparator
    Sham Arm

    Other: Sham LiST Device + 5mg Tadalafil

Interventions

  • OtherDornier Aries2 LiST Device + 5mg Tadalafil (1)

    Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.

  • OtherDornier Aries2 LiST Device + 5mg Tadalafil (2)

    Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.

  • OtherSham LiST Device + 5mg Tadalafil

    Patients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

06

What researchers measure

Primary outcomes

  1. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

    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. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

    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. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

    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 16 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 16-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 16-weeks follow up period will be reported

    Time frame: 20 weeks

07

Study locations

1 of 1 sites recruiting
  • G.Gennimatas Hospital
    Thessaloniki, 54621, Greece
    Recruiting
    • Paraskevi Kapoteli · Contactpkapotel@auth.gr · 6948581395
    • Dimitrios Hatzichristou, Prof. · Principal investigator
08

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

Started Aug 2018 (actual). Primary completion is estimated for Sep 2022, 49 months after the start.

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 planned 49 months is above 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 27, 2018
Primary completionEst.
Sep 2022
CompletionEst.
Dec 2022
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 ↗
09

Registry details

Key details

Study ID
NCT03642366
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 27, 2018
Primary completion
Sep 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
May 5, 2022

Study contacts

Paraskevi Kapoteli
Contact
pkapotel@auth.gr
2310963105 ext. +30
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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