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Trial record 19 of 38 for:    erectile dysfunction | "Erectile Dysfunction" AND "Erectile Dysfunction" | shock wave

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

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ClinicalTrials.gov Identifier: NCT03642366
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

Brief 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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Other: Dornier Aries2 LiST Device + 5mg Tadalafil (1) Other: Dornier Aries2 LiST Device + 5mg Tadalafil (2) Other: Sham LiST Device + 5mg Tadalafil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Low-intensity Shockwaves Therapy Co-administered With Tadalafil 5mg for the Treatment of Severe, Vasculogenic Erectile Dysfunction:Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 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: Active Arm 1 Other: Dornier 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.

Active Comparator: Active Arm 2 Other: Dornier 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.

Sham Comparator: Sham Arm Other: Sham 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.




Primary Outcome Measures :
  1. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF) [ 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. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF) [ 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. The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF) [ Time Frame: baseline and 16 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 16-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: 20 weeks ]
    Potential treatment related adverse events after the first LI-ESWT session and during the 16-weeks follow up period will be reported



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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. 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:

  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.

19. 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.

20. History of adverse events in response to tadalafil, which would 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): NCT03642366


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

Locations
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
Principal Investigator: Dimitrios Hatzichristou, Prof. Institute for the Study of Urological Diseases, Thessaloniki, Greece

Responsible Party: Dimitrios Hatzichristou, Chairman, Institute for the Study of Urological Diseases, Greece
ClinicalTrials.gov Identifier: NCT03642366     History of Changes
Other Study ID Numbers: 10673/2018
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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

Keywords provided by Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece:
Low Intensity Shockwave Therapy

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