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Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT04136288
Recruitment Status : Not yet recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Gregory A. Broderick, Mayo Clinic

Brief Summary:
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: MoreNova Not Applicable

Detailed Description:

ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.

The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy).

LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency
Estimated Study Start Date : December 2, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Males with erectile dysfunction (ED)
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
Device: MoreNova
Shockwave therapy delivered to the genital area with low dose shocks




Primary Outcome Measures :
  1. Change in cavernosal artery inflow [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]
    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

  2. Change in peak systolic velocity [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]
    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

  3. Change in diastolic velocity [ Time Frame: Baseline, treatment 6, 3-4 month follow up ]
    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

  4. Change in erection hardness [ Time Frame: Baseline, treatment 6, 1 month follow up, 3-4 month follow up ]
    Measured using a self-reported erection hardness score (EHS) using a scale of 0 is penis does not change and 4 is penis is completely hard and fully rigid



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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his informed and signed written consent
  • The patient is a male
  • Between 40 to and including 55 years of age
  • The patient has ED for longer than 1 year but less than 5 years.
  • The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
  • IIEF-EF Domain score of 17-20
  • Evidence Based Criteria: Doppler Clinical Exam

Exclusion Criteria:

  • The patient is participating in another study that may interfere with the results or conclusions of this study
  • History of radical prostatectomy or extensive pelvic surgery
  • Past radiation therapy of the pelvic region within 12 months prior to enrollment
  • Recovering from cancer within 12 months prior to enrollment
  • Neurological disease which effects erectile function
  • Psychiatric disease which effects erectile function
  • The patient is taking blood thinners
  • History of Diabetes Mellitus
  • History of Coronary Artery Disease
  • Evidence Based Criteria: Doppler Clinical Exam
  • Severe erectile dysfunction with IIEF-EF domain score < 16

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): NCT04136288


Contacts
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Contact: Andrew Hendrix (904) 953-2000 Hendrix.Andrew@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Not yet recruiting
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Gregory Broderick, MD Mayo Clinic

Additional Information:
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Responsible Party: Gregory A. Broderick, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04136288     History of Changes
Other Study ID Numbers: 18-001246
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders