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Search / Trial NCT04136288

Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Launched by MAYO CLINIC · Oct 21, 2019

Trial Information

Current as of May 21, 2025

Completed

Keywords

ClinConnect Summary

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 E...

Gender

MALE

Eligibility 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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Jacksonville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Gregory Broderick, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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