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Trial record 20 of 62 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

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

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ClinicalTrials.gov Identifier: NCT03641846
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

Brief 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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Low Intensity Shockwave Therapy Other: DornierAries2 LiST device + 5 mg Tadalafil Other: DornierAries2 LiST device + Placebo Pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: "Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction: a Randomized Placebo Controlled Two-parallel Arms Trial, Comparing 6 Sessions, With Daily Tadalafil 5mg vs Placebo"
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
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
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

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
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.




Primary Outcome Measures :
  1. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) [ Time Frame: baseline and 12-week follow-up visit ]
    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)


Secondary Outcome Measures :
  1. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) [ Time Frame: baseline and 4-week follow-up visit ]
    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)

  2. Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) [ Time Frame: baseline and 24-week follow-up visit ]
    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)

  3. Change in Sexual Encounter Profile Question 3 (SEP3) score [ Time Frame: baseline and 4-week follow-up visit ]
    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?"

  4. Change in Sexual Encounter Profile Question 3 (SEP3) score [ Time Frame: baseline and 12-week follow-up visit ]
    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?"

  5. Change in Sexual Encounter Profile Question 3 (SEP3) score [ Time Frame: baseline and 24-week follow-up visit ]
    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?"

  6. Number of patients with treatment related adverse events [ Time Frame: 28 weeks ]
    Potential treatment related adverse events after the first LI-ESWT session and during the 6 month follow up period will be reported



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641846


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

Locations
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Greece
G.Gennimatas Hospital Recruiting
Thessaloniki, Greece, 54621
Contact: Paraskevi Kapoteli    6948581395 ext +30    pkapotel@auth.gr   
Principal Investigator: Dimitrios Hatzichristou, Prof.         
Sponsors and Collaborators
Institute for the Study of Urological Diseases, Greece
Investigators
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Principal Investigator: Dimitrios Hatzichristou, Prof. Institute for the Study of Urological Diseases, Thessaloniki, Greece

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Responsible Party: Dimitrios Hatzichristou, Chairman, Institute for the Study of Urological Diseases, Greece
ClinicalTrials.gov Identifier: NCT03641846     History of Changes
Other Study ID Numbers: 10672/2018
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents