Status:
COMPLETED
Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Lead Sponsor:
Mayo Clinic
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-55 years
Phase:
NA
Brief Summary
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).
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 injectio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04136288
Start Date
December 1 2019
End Date
July 1 2023
Last Update
November 12 2024
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224