Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Mayo Clinic6 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

MoreNovaDEVICE

Shockwave therapy delivered to the genital area with low dose shocks

Eligibility

Sex: MALEMin age: 40 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Change in Right Resistive Index

Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis.

Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

Change in Right Peak Systolic Velocity

Peak systolic velocity (PSV): The maximum velocity of blood flow during erection. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy.

Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

Change in Right Diastolic Velocity

Diastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

Erection Hardness Score (EHS)

Measured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum). 0- Penis does not enlarge, 1- Penis is larger but not hard, 2- Penis is hard but not hard enough for penetration, 3- Penis is hard enough for penetration but not completely hard, or 4-Penis is completely hard and fully rigid. A lower score indicates a worse outcome. A higher score indicates a better outcome.

Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

International Index of Erectile Function (IIEF - EF) Questionnaire

Data from ClinicalTrials.gov

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