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

November 12, 2017 updated by: Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54621
        • G.Gennimatas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 month follow up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 3 month follow up visit
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
baseline and 6 month follow up visit.
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
baseline and 6 month follow up visit.
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
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for the Study of Urological Diseases, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2015

Primary Completion (Actual)

September 13, 2016

Study Completion (Actual)

September 13, 2016

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 12, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1490/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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