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Trial record 23 of 37 for:    erectile dysfunction | "Erectile Dysfunction" AND "Erectile Dysfunction" | shock wave

Effect of Repeating Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED)

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ClinicalTrials.gov Identifier: NCT03089372
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 evaluates the efficacy and safety of repetitive treatments of Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is, and completed 6 or 12 sessions of LI-ESWT with Aries device during the last 6 month.

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

Detailed Description:

This is an extension, 2 parallel arms, clinical trial of a previous study in which patients were PDE5I users/responders and were randomized to receive either one or two shockwave treatment sessions per week for a total of 6 weeks, without treatment interval. After completing the 6-month follow up of the first trial , ED patients will be screened, in order to identify if the IIEF ED domain is still abnormal (<26). Afterwards, the 2 groups of the first study will follow the 2 different treatment protocols (once vs twice per week). All patients will receive 6 treatment sessions with Aries, with the same energy level. First treatment session will take place between days 0-28 from the day of the 6-month follow up. All patients will agree and sign a new Informed Consent Form. Therefore, patients who took 6 sessions once a week (Group A in the previous trial) will be switched to take 6 sessions twice a week in 3 weeks, and those already treated with 12 sessions twice a week (Group B in the previous trial) will be treated with 6 sessions once a week.

Study visits and duration

Baseline - Visit: the basic work-up will take place, including medical and sexual history, as well as lab tests, if indicated by medical history. The IIEF-ED domain will be measured, as well as the Sexual Encounter Profile (SEP) for the last 4-week period with at least 4 attempts for intercourse (without PDE5i use). The study criteria will be checked and if patients are eligible (IIEF-ED domain <26), they will receive their first repetitive treatment, either on the same day as the 6-month follow up of the previous study or within maximum 4 weeks.

Treatment Visits: In all treatment visits, patients will receive active LI-ESWT treatment, according to the study protocol. Group A will receive treatment twice per week for three weeks and Group B will receive treatment once per week for six weeks. Interval between 2 treatments will be 7+2days for Group B and 3+1 day for Group A. Adverse events and changes in concomitant medication will be recorded. PDE5i intake is prohibited throughout the treatment period.At visit 6 penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.

Follow-up visit 1 - 3 (4, 12 and 24 weeks post treatment): the SEP diaries will be returned and the IIEF-ED domain will be completed for the 4 weeks prior to the aforementioned timepoints, during which no PDE5i intake is allowed. The document of the visit (protocol compliance, adverse events) will be completed. At week 12, triplex ultrasonography will be performed by the standard protocol.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) in Patients With Vasculogenic Erectile Dysfunction (ED): Evaluation of the Efficacy of Re-treatment.
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Patients will receive two sessions of LI-ESWT per week for a 3 week period (6 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 one session of LI-ESWT per week for a 6 week period (6 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: 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: 27 months (Group A) ,30 months (Group B) ]
    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. Patients who completed the 6 months follow-up of a previous study including 6 or 12 sessions of LI-ESWT with Aries device and still have an abnormal IIEF ED domain (< 26)
  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): NCT03089372


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: NCT03089372     History of Changes
Other Study ID Numbers: 4240/2016
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