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Trial record 22 of 37 for:    erectile dysfunction | "Erectile Dysfunction" AND "Erectile Dysfunction" | shock wave

Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol

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ClinicalTrials.gov Identifier: NCT03089294
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

Brief Summary:
The present study aims to identify the efficacy saturation effect of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and safety of 4 different session frequency protocols will be compared.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Aries ED device Not Applicable

Detailed Description:

This is a randomized, 4 parallel arms, clinical trial with an 18-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 96 men with vasculogenic ED, an International Index of Erectile Function ED (IIEF-ED) domain score between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec) in the last 6 months. Additionally, they will be asked to complete the SEP diaries. Patients will be randomized to receive shockwave treatments (12 sessions for all subjects), either twice a week (total of 6 weeks) or three times a week (total of 4 weeks) at energy level 4 or 7, without treatment interval.

Study visits and duration

Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as well as necessary lab tests, if needed. One month wash-out period will follow. During this period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least 2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography, unless they have already done so in the last 6 months.Also penile dimensions in both flaccid and erect state will be measured.

Visit 2 (day 28 + 3 days): all patients will complete the IIEF-ED domain and will be randomized to one of the four parallel study groups, using an online program. Groups A and C will receive treatment twice per week, at energy level 4 and 7 respectively. Groups B and D will receive treatment three times per week, at energy level 4 and 7 respectively. PDE5i use is prohibited throughout the study.

Treatment Visits: There will be 12 active treatment visits for all 4 Groups. Patients will receive LI-ESWT, according to the study protocol. Interval between 2 treatments will be 3+1 days for Groups A and C (twice/week) whereas 1+1 day for Groups B and D (three times/week). At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.

Follow-up visits 1 - 3 (4, 12 ,24 and 48 weeks post treatment): Patients will complete the IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week 12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit window, whereas for weeks 12, 24 and 48 there is a + 2 weeks visit window.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shock Wave Treatment Patients With Vasculogenic Erectile Dysfunction: Standardisation of Treatment Protocol
Actual Study Start Date : May 30, 2016
Actual Primary Completion Date : June 6, 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 4 (12 sessions totally)
Device: Aries ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)

Active Comparator: Group B
Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 4 (12 sessions totally)
Device: Aries ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)

Active Comparator: Group C
Patients will receive 2 sessions of LI-ESWT per week for a 6 week period with energy level 7 (12 sessions totally)
Device: Aries ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)

Active Comparator: Group D
Patients will receive 3 sessions of LI-ESWT per week for a 4 week period with energy level 7 (12 sessions totally)
Device: Aries ED device
The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)




Primary Outcome Measures :
  1. The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF [ Time Frame: baseline and 6 month follow up visit ]

    MCID is defined according to baseline ED severity as:

    • Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline.
    • Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline
    • Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline


Secondary Outcome Measures :
  1. Change in the EF domain score of the IIEF [ Time Frame: baseline, 6 month follow up visit and 12 month follow up visit ]
    EF domain of the IIEF questionnaire will be completed

  2. Change in Sexual Encounter Profile Question 3 (SEP3) score [ Time Frame: baseline, 6 month follow up visit and 12 month follow up visit ]
    The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported

  3. Change in mean peak systolic velocity (PSV) [ Time Frame: baseline and 3 month follow up visit ]
    Mean peak systolic velocity will be measured by penile triplex ultrasonography by the same investigator.

  4. Number of patients with treatment related adverse events [ Time Frame: 54 weeks (Group A and Group C), 52 weeks (Group B and Group D) ]
    Potential treatment related adverse events after the first LI-ESWT session and during the 12 month follow up period will be reported



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Consent to participate
  2. Age >18
  3. Presence of vasculogenic erectile dysfunction for at least 6 months
  4. Positive response to PDE5i
  5. IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
  6. Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
  7. Stable heterosexual relationship for more than 3 months
  8. Sexually active and agree to suspend all ED therapy for the duration of study

Exclusion Criteria:

  1. Any cause of ED other than vascular related
  2. Previous radiation therapy to pelvis
  3. History of radical prostatectomy
  4. Clinically significant chronic haematological disease
  5. Cardiovascular conditions that prevent sexual activity
  6. Peyronie's Disease or penile curvature
  7. History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
  8. Anti-androgens oral or injectables androgens
  9. Untreated Hypogonadism as demonstrated by abnormal testosterone levels
  10. Malignancy within the past 5 years
  11. Any unstable medical, psychiatric condition or spinal cord injury
  12. Anatomical or neurological abnormalities in the treatment area
  13. Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
  14. Known allergy to ultrasound gel

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): NCT03089294


Locations
Greece
G.Gennimatas Hospital
Thessaloniki, Greece, 54621
Sponsors and Collaborators
Institute for the Study of Urological Diseases, Greece
Investigators
Principal Investigator: Dimitrios Hatzichristou, Prof. Institute for the Study of Urological Diseases (ISUD)

Publications:
Responsible Party: Dimitrios Hatzichristou, President, Institute for the Study of Urological Diseases, Greece
ClinicalTrials.gov Identifier: NCT03089294     History of Changes
Other Study ID Numbers: 13771/2016
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Erectile Dysfunction
Low intensity extracorporeal shock wave treatment

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders