Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

NCT ID: NCT04136288

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-07-01

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 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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MoreNova

Intervention Type: DEVICE

Shockwave therapy delivered to the genital area with low dose shocks

Interventions

MoreNova

Shockwave therapy delivered to the genital area with low dose shocks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Gregory A. Broderick

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory Broderick, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-001246

Identifier Type: -

Identifier Source: org_study_id