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Trial record 17 of 38 for:    erectile dysfunction | "Erectile Dysfunction" AND "Erectile Dysfunction" | shock wave

6 vs 12 Sessions in Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

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ClinicalTrials.gov Identifier: NCT03089307
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

Brief Summary:
The present study aims to identify and compare the efficacy and safety of two different session frequency protocols (once vs twice per week) 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

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

Detailed Description:

This is a randomized, 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 randomized 42 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec). Then the 42 pts will be randomized to receive either one or two shockwave treatment sessions per week, without treatment interval. Every week all subjects may have at least one attempt for intercourse. All patients will complete 6 weeks of treatment.

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. all patients will complete the IIEF-ED domain and will be randomized (1:1) to one of the two parallel study groups, using an online program. Groups A will receive treatment once per week for 6 weeks (6 sessions totally), and Groups B will receive treatment two times per week for 6 weeks (12 sessions totally). PDE5i use is prohibited throughout the study.

Treatment Visits: Patients will receive LI-ESWT , according to the study protocol.Interval between 2 treatments will be 7+2days for Group A and 3+1 day for Group B.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 and 24 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 and 24 there is a + 2 weeks visit window.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients (n=44) will be randomised into 2 groups to receive low intensity extracorporeal shock wave treatment for a 6 weeks period utilising the Dornier Aries ED device.Group A (n=21) will receive 6 sessions (one session per week) and group B (n=21) will receive 12 sessions (2 sessions per week).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED): Comparison of 6 Sessions Once a Week vs 12 Sessions Twice Per Week
Actual Study Start Date : August 18, 2015
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : September 13, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally).
Device: Dornier 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 two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally).
Device: Dornier 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: at 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 and 6 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 and 6 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: 30 weeks ]
    Potential treatment related adverse events after the first LI-ESWT session and during the 6 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): NCT03089307


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: NCT03089307     History of Changes
Other Study ID Numbers: 1490/15
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
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